-
Consulting medical
maintenant
-
Baxter Healthcare Inc
- Senior Project Manager
2018 - 2018
Regulatory & Quality & Clinical
Braine l'alleud, Belgium
* CER expert Meddev 2.7.1 rev 4 and MDR EU 2017/745
* .MDSAP
* PMS, PMCF
* Risk Management
-
Baxter Healthcare Inc
- Senior Project Manager
2018 - 2018
Regulatory & Quality & Clinical
Braine l'alleud, Belgium
* CER expert Meddev 2.7.1 rev 4 and MDR EU 2017/745
* .MDSAP
* PMS, PMCF
* Risk Management
-
Baxter Healthcare Inc
- Senior Project Manager
2018 - 2018
Regulatory & Quality & Clinical
Braine l'alleud, Belgium
* CER expert Meddev 2.7.1 rev 4 and MDR EU 2017/745
* .MDSAP
* PMS, PMCF
* Risk Management
-
Confidential Company
- Auditor
2018 - 2018
* MD Class III
* Audit on ISO 13485-2016 and MDSAP
-
Confidential Company
- Auditor
2018 - 2018
* MD Class III
* Audit on ISO 13485-2016 and MDSAP
-
Confidential Company
- Auditor
2018 - 2018
* MD Class III
* Audit on ISO 13485-2016 and MDSAP
-
Helios
- Auditor Quality
Baia Mare
2018 - 2018
* Audit to ISO 13485-2016 from version 2012
* Gap Analysis
* Remediation plan
-
Helios
- Auditor Quality
Baia Mare
2018 - 2018
* Audit to ISO 13485-2016 from version 2012
* Gap Analysis
* Remediation plan
-
Helios
- Auditor Quality
Baia Mare
2018 - 2018
* Audit to ISO 13485-2016 from version 2012
* Gap Analysis
* Remediation plan
-
Nemera
- Senior Consultant Regulatory Affairs for USA
2017 - 2018
* Lead the pathway for registration of an eye-dropper in the USA
* Interaction with FDA
* Calculation of the PDE level (Silver) -Risk Analysis
-
Nemera
- Senior Consultant Regulatory Affairs for USA
2017 - 2018
* Lead the pathway for registration of an eye-dropper in the USA
* Interaction with FDA
* Calculation of the PDE level (Silver) -Risk Analysis
-
Nemera
- Senior Consultant Regulatory Affairs for USA
2017 - 2018
* Lead the pathway for registration of an eye-dropper in the USA
* Interaction with FDA
* Calculation of the PDE level (Silver) -Risk Analysis
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xxxxxx
- QA Senior Consultant & Thermo Fisher
2017 - 2017
QA Senior Consultant
Thermo Fisher Scientific, Lyon, France
* Manage the rollout of the new QMS ISO 9001-2015 & ISO 13485-2016
* WI and Forms writing
* Training of 285 employees on the new SOP's
* Lead Audits of G-Med
* Perform Management reviews meetings and Internal Audits
-
xxxxxx
- QA Senior Consultant & Thermo Fisher
2017 - 2017
QA Senior Consultant
Thermo Fisher Scientific, Lyon, France
* Manage the rollout of the new QMS ISO 9001-2015 & ISO 13485-2016
* WI and Forms writing
* Training of 285 employees on the new SOP's
* Lead Audits of G-Med
* Perform Management reviews meetings and Internal Audits
-
xxxxxx
- QA Senior Consultant & Thermo Fisher
2017 - 2017
QA Senior Consultant
Thermo Fisher Scientific, Lyon, France
* Manage the rollout of the new QMS ISO 9001-2015 & ISO 13485-2016
* WI and Forms writing
* Training of 285 employees on the new SOP's
* Lead Audits of G-Med
* Perform Management reviews meetings and Internal Audits
-
Laboratoires Genevrier
- QA Auditor
ANTIBES
2017 - 2017
* Audit of their QMS according to 13485-2016
* Review of theirCER on Meddev 2.7.1 rev 4
* Strategy on ISO 9001-2015 and ISO 13485-2016
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Laboratoires Genevrier
- QA Auditor
ANTIBES
2017 - 2017
* Audit of their QMS according to 13485-2016
* Review of theirCER on Meddev 2.7.1 rev 4
* Strategy on ISO 9001-2015 and ISO 13485-2016
-
Laboratoires Genevrier
- QA Auditor
ANTIBES
2017 - 2017
* Audit of their QMS according to 13485-2016
* Review of theirCER on Meddev 2.7.1 rev 4
* Strategy on ISO 9001-2015 and ISO 13485-2016
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PDSA
- Quality Auditor
2017 - 2017
-
PDSA
- Quality Auditor
2017 - 2017
-
PDSA
- Quality Auditor
2017 - 2017
-
Gynetics
- Regulatory & Quality Advisor
2017 - 2017
* CER review as Meddev 2.7-1 revision 4
* Update of Sop's for ISO 13485-2016
* Regulatory Strategy
* Certification of ETO sterilization
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CEMAG
- Quality Manager
2017 - 2017
* CE mark for a device IIa
* Writing the procedures under production control
* Auditing suppliers
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CEMAG
- Quality Manager
2017 - 2017
* CE mark for a device IIa
* Writing the procedures under production control
* Auditing suppliers
-
Gynetics
- Regulatory & Quality Advisor
2017 - 2017
* CER review as Meddev 2.7-1 revision 4
* Update of Sop's for ISO 13485-2016
* Regulatory Strategy
* Certification of ETO sterilization
-
CEMAG
- Quality Manager
2017 - 2017
* CE mark for a device IIa
* Writing the procedures under production control
* Auditing suppliers
-
Gynetics
- Regulatory & Quality Advisor
2017 - 2017
* CER review as Meddev 2.7-1 revision 4
* Update of Sop's for ISO 13485-2016
* Regulatory Strategy
* Certification of ETO sterilization
-
xxxx
- Auditeur qualite
2017 - 2017
* Proposed strategies to start implementing EU MDR
-
Regen Lab Sa
- Regulatory & Quality Manager
2017 - 2017
* Solve the mutation from a closed Notified body to another Notified body
* Mutation of the CE mark to the new notified body
* CER (Meddev 2.7 rev 4) rewrite of some SOP's (PMS)
-
xxxx
- Auditeur qualite
2017 - 2017
* Proposed strategies to start implementing EU MDR
-
Regen Lab Sa
- Regulatory & Quality Manager
2017 - 2017
* Solve the mutation from a closed Notified body to another Notified body
* Mutation of the CE mark to the new notified body
* CER (Meddev 2.7 rev 4) rewrite of some SOP's (PMS)
-
Regen Lab Sa
- Regulatory & Quality Manager
2017 - 2017
* Solve the mutation from a closed Notified body to another Notified body
* Mutation of the CE mark to the new notified body
* CER (Meddev 2.7 rev 4) rewrite of some SOP's (PMS)
-
xxxx
- Auditeur qualite
2017 - 2017
* Proposed strategies to start implementing EU MDR
-
Septodont
- Regulatory Strategist
Saint Maur des Fossés Cedex
2016 - 2016
* Writing strategies for introduction of a new medical device in the USA
-
Septodont
- Regulatory Strategist
Saint Maur des Fossés Cedex
2016 - 2016
* Writing strategies for introduction of a new medical device in the USA
-
Septodont
- Regulatory Strategist
Saint Maur des Fossés Cedex
2016 - 2016
* Writing strategies for introduction of a new medical device in the USA
-
Instent
- AQ Advisor
2016 - 2016
* Building the QMS in regards to ISO 13485-2016
* Supervising two direct reports AQ junior
-
Zimmer
- AQ Senior Consultant
2016 - 2016
* Organization of the remediation plan with 52 consultants in design and QMS
* Update of the ISO 13485-2003 to ISO 13485-2016
* Remediation plan
-
Instent
- AQ Advisor
2016 - 2016
* Building the QMS in regards to ISO 13485-2016
* Supervising two direct reports AQ junior
-
Instent
- AQ Advisor
2016 - 2016
* Building the QMS in regards to ISO 13485-2016
* Supervising two direct reports AQ junior
-
Zimmer
- AQ Senior Consultant
2016 - 2016
* Organization of the remediation plan with 52 consultants in design and QMS
* Update of the ISO 13485-2003 to ISO 13485-2016
* Remediation plan
-
Instent
- AQ Advisor
2016 - maintenant
* Building the QMS in regards to ISO 13485-2016
* Supervising two reports AQ junior
AQ Advisor ,
-
Zimmer
- AQ Senior Consultant
2016 - maintenant
* Organization of the remediation plan with 52 consultants in design and QMS ;
-
Zimmer
- AQ Senior Consultant
2016 - 2016
* Organization of the remediation plan with 52 consultants in design and QMS
* Update of the ISO 13485-2003 to ISO 13485-2016
* Remediation plan
-
Unither
- AQ Advisor
Paris
2016 - 2016
* Blank audit on ISO 13485-2016
* Plan of remediation
* Advise the company on upgrading from ISO 13485-2003 to ISO 13485-2016
-
Unither
- AQ Advisor
Paris
2016 - 2016
* Blank audit on ISO 13485-2016
* Plan of remediation
* Advise the company on upgrading from ISO 13485-2003 to ISO 13485-2016
-
Unither
- AQ Advisor
Paris
2016 - 2016
* Blank audit on ISO 13485-2016
* Plan of remediation
* Advise the company on upgrading from ISO 13485-2003 to ISO 13485-2016
-
NOVABIOTICS, UK
- Head of Regulatory Affairs
2016 - 2016
* Orphan Drug designation submission
* PRIME projects
* Clinical Strategy EMEA and USA
-
NOVABIOTICS, UK
- Head of Regulatory Affairs
2016 - 2016
* Orphan Drug designation submission
* PRIME projects
* Clinical Strategy EMEA and USA
-
NOVABIOTICS, UK
- Head of Regulatory Affairs
2016 - 2016
* Orphan Drug designation submission
* PRIME projects
* Clinical Strategy EMEA and USA
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Soluscope
- AQ advisor
Aubagne
2016 - 2016
* Blank audit on CFR21 Part 820
* Blank audit on Canadian QMS
* Gap Analysis
* Preparation of the remediation plan
* List of testing for Canadian Health
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Soluscope
- AQ advisor
Aubagne
2016 - 2016
* Blank audit on CFR21 Part 820
* Blank audit on Canadian QMS
* Gap Analysis
* Preparation of the remediation plan
* List of testing for Canadian Health
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Soluscope
- AQ advisor
Aubagne
2016 - 2016
* Blank audit on CFR21 Part 820
* Blank audit on Canadian QMS
* Gap Analysis
* Preparation of the remediation plan
* List of testing for Canadian Health
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World Wide Clinical Trials Inc
- Head of European Operations, Clinical and Regulatory
2015 - 2015
* Provide Regulatory Strategy for Start-up phase trials on a GLOBAL scale
* Provide advice and review on submissions to CTA and EC
-
World Wide Clinical Trials Inc
- Head of European Operations, Clinical and Regulatory
2015 - 2015
* Provide Regulatory Strategy for Start-up phase trials on a GLOBAL scale
* Provide advice and review on submissions to CTA and EC
-
World Wide Clinical Trials Inc
- Head of European Operations, Clinical and Regulatory
2015 - 2015
* Provide Regulatory Strategy for Start-up phase trials on a GLOBAL scale
* Provide advice and review on submissions to CTA and EC
-
FDA Audit
- Advisor
2015 - 2015
* Review main SOP's such as CAPA, Change Control, and Design Change
* Blank audit before FDA audit, write SOP's in compliance with CFR21 Part 820
* Advisor during FDA audit - resulting in no major findings
-
FDA Audit
- Advisor
2015 - 2015
* Review main SOP's such as CAPA, Change Control, and Design Change
* Blank audit before FDA audit, write SOP's in compliance with CFR21 Part 820
* Advisor during FDA audit - resulting in no major findings
-
FDA Audit
- Advisor
2015 - 2015
* Review main SOP's such as CAPA, Change Control, and Design Change
* Blank audit before FDA audit, write SOP's in compliance with CFR21 Part 820
* Advisor during FDA audit - resulting in no major findings
-
NovusLife, LLC
- Head of European Operations
2014 - 2015
* Regulatory and Clinical Affairs Consulting as well as marketing authorizations in EMEA, US, and Far-East regions
* Interact with authorities, notified bodies and other approving bodies for fast and smooth product approval
* Identify potential risks in submissions and anticipated regulatory responses through scenario planning
* Prepare firms with mock auditing scenarios
* Compliance of QMS for CFR 21 Part 820, ISO 13485
-
NovusLife, LLC
- Head of European Operations
2014 - 2015
* Regulatory and Clinical Affairs Consulting as well as marketing authorizations in EMEA, US, and Far-East regions
* Interact with authorities, notified bodies and other approving bodies for fast and smooth product approval
* Identify potential risks in submissions and anticipated regulatory responses through scenario planning
* Prepare firms with mock auditing scenarios
* Compliance of QMS for CFR 21 Part 820, ISO 13485
-
NovusLife, LLC
- Head of European Operations
2014 - 2015
* Regulatory and Clinical Affairs Consulting as well as marketing authorizations in EMEA, US, and Far-East regions
* Interact with authorities, notified bodies and other approving bodies for fast and smooth product approval
* Identify potential risks in submissions and anticipated regulatory responses through scenario planning
* Prepare firms with mock auditing scenarios
* Compliance of QMS for CFR 21 Part 820, ISO 13485
-
NovusLife, LLC
- Head of European Operations & Head of European Operations
2014 - 2015
As Head of European Operations, I am responsible for identifying potential NovusLife projects that fit into
our service offerings. NovusLife will assist innovative European medical device as well as rare disease firms
with their challenges; especially ones having to do with entering the US (and other country) markets.
Conversely, I will lead efforts for NovusLife's US clients to enter into the European market. Sample
offerings include:
Page1Regulatory and Clinical Affairs Consulting as well as marketing authorizations in EMEA, US, and Far-East
regions
Interact with authorities, notified bodies and other approving bodies for fast and smooth product approval
Identify potential risks in submissions and anticipated regulatory responses through scenario planning
Prepare firms with mock auditing scenarios
Compliance of QMS for CFR 21 Part 820, ISO 13485
Manage client vendor relationships to insure successful trial and project outcomes
Fournitures Hospitalieres, Quimper, France ,
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Global Life Sciences Consulting Firm
- Senior Associate
2014 - maintenant
Full-service, professional consulting firm for FDA regulated industries. Maetrics leverages its wealth of experience to provide cost-effective solutions that are based on nearly 30 years of experience in developing and implementing compliant, sustainable best practices that will withstand regulatory scrutiny. Maetrics is a global organization with offices throughout the United States and in Europe. We routinely use our exclusive capabilities to deliver on consulting engagements that vary from short-term expert advice to deployment of a large-scale, multifaceted project team involving dozens of consultants across multiple sites and continents. Recent and ongoing projects have included multi-national, multi-billion dollar device firms to start-up pharma shops. Whether you are looking for a resolution to a compliance issue or a solution for outsourcing your supplier management, Maetrics can help.
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Global Life Sciences Consulting Firm
- Senior Associate
2014 - 2014
* Full-service, professional consulting for FDA regulated industries
-
Global Life Sciences Consulting Firm
- Senior Associate
2014 - 2014
* Full-service, professional consulting for FDA regulated industries
-
Global Life Sciences Consulting Firm
- Senior Associate
2014 - 2014
* Full-service, professional consulting for FDA regulated industries
-
ARAZY Group Consultants Inc.
- Senior Operation Manager - EMEA
2013 - 2014
Regulatory affairs solutions throughout the product life cycle - from early development to post-market activities.
* Provided strategy for Global Registrations for IVD, Medical devices, Active Devices, Cosmetics
-
ARAZY Group Consultants Inc.
- Senior Operation Manager - EMEA
2013 - 2014
Regulatory affairs solutions throughout the product life cycle - from early development to post-market activities.
* Provided strategy for Global Registrations for IVD, Medical devices, Active Devices, Cosmetics
-
ARAZY Group Consultants Inc.
- Senior Operation Manager -EMEA
2013 - maintenant
* Arazy Group is a global, multifaceted regulatory affairs firm that provides all types of medical device manufacturers with innovative, client-specific solutions throughout the product life cycle - from early development to post-market activities. Provided strategy for Global Registrations for IVD, Medical devices, Active Devices , Cosmetics
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ARAZY Group Consultants Inc.
- Senior Operation Manager - EMEA
2013 - 2014
Regulatory affairs solutions throughout the product life cycle - from early development to post-market activities.
* Provided strategy for Global Registrations for IVD, Medical devices, Active Devices, Cosmetics
-
Ehcor Consulting Group
- Senior Director of Regulatory affairs
2012 - 2013
* Provided strategy and marketing consulting services, regulatory & clinical affairs consulting and marketing authorizations in EMEA, U.S.A. and Asia Pacific.
-
Ehcor Consulting Group
- Senior Director of Regulatory affairs
2012 - 2013
* Provided strategy and marketing consulting services, regulatory & clinical affairs consulting and marketing authorizations in EMEA, U.S.A. and Asia Pacific. ;
-
Consulting medical
- Senior porject manager
2012 - maintenant
-
Ehcor Consulting Group
- Senior Director of Regulatory affairs
2012 - 2013
* Provided strategy and marketing consulting services, regulatory & clinical affairs consulting and marketing authorizations in EMEA, U.S.A. and Asia Pacific.
-
Ehcor Consulting Group
- Senior Director of Regulatory affairs
2012 - 2013
* Provided strategy and marketing consulting services, regulatory & clinical affairs consulting and marketing authorizations in EMEA, U.S.A. and Asia Pacific.
-
BECKMAN-COULTER
- Senior Manager & Clinical Studies Scientist
2012 - 2012
* European Lead on studies for Molecular Diagnostics, Immunoassay, Flow Cytometry, Clinical Chemistry Systems, and Registration/Beta Studies on new automation-connected products
* Closely cooperate with the U.S.-based Research & Development centres on new product development initiatives
* Company representative at the European Diagnostics Manufacturer Association, serving on the Regulatory Affairs Committee Task Force
* Responsible for the expansion and development of the Global Notice on the 2012 EU Directive on IVD's
-
BECKMAN-COULTER
- Senior Manager & Clinical Studies Scientist
2012 - 2012
* European Lead on studies for Molecular Diagnostics, Immunoassay, Flow Cytometry, Clinical Chemistry Systems, and Registration/Beta Studies on new automation-connected products
* Closely cooperate with the U.S.-based Research & Development centres on new product development initiatives
* Company representative at the European Diagnostics Manufacturer Association, serving on the Regulatory Affairs Committee Task Force
* Responsible for the expansion and development of the Global Notice on the 2012 EU Directive on IVD's
-
QMS
- Auditor & Auditor
2012 - maintenant
* Auditor of the QMS to compliance ISO 13485-2016
* Auditor for compliance with MDR (published
-
QMS
- Auditor & Auditor
2012 - maintenant
* Auditor of the QMS to compliance ISO 13485-2016
* Auditor for compliance with MDR (published
-
BECKMAN-COULTER
- Senior Manager & Clinical Studies Scientist
2012 - 2012
* European Lead on studies for Molecular Diagnostics, Immunoassay, Flow Cytometry, Clinical Chemistry Systems, and Registration/Beta Studies on new automation-connected products
* Closely cooperate with the U.S.-based Research & Development centres on new product development initiatives
* Company representative at the European Diagnostics Manufacturer Association, serving on the Regulatory Affairs Committee Task Force
* Responsible for the expansion and development of the Global Notice on the 2012 EU Directive on IVD's
-
BECKMAN-COULTER
- Senior Manager & Clinical Studies Scientist
2012 - 2012
* European Lead on studies for Molecular Diagnostics, Immunoassay, Flow Cytometry, Clinical Chemistry Systems, and Registration/Beta Studies on new automation-connected products
* Closely cooperate with the U.S.-based Research & Development centers on new product development initiatives
* Company representative at the European Diagnostics Manufacturer Association, serving on the Regulatory Affairs Committee Task Force
* Responsible for the expansion and development of the Global Notice on the 2012 EU Directive on IVD's ;
-
QMS
- Auditor & Auditor
2012 - maintenant
* Auditor of the QMS to compliance ISO 13485-2016
* Auditor for compliance with MDR (published
-
Maquet Intervascular
- Regulatory Advisor
2012 - 2012
on submission of a 510K.
Senior Director of Regulatory affairs
* Collaborated with the Department AQ/QC, conducting AQ system review in compliance with CFR 21 Part 820 and developing Sop's for change control, CAPA, and management review
-
Maquet Intervascular
- Regulatory Advisor
2012 - 2012
on submission of a 510K.
Senior Director of Regulatory affairs
* Collaborated with the Department AQ/QC, conducting AQ system review in compliance with CFR 21 Part 820 and developing Sop's for change control, CAPA, and management review
-
Maquet Intervascular
- Senior Director of Regulatory affairs
2012 - 2012
* Collaborated with the Department AQ/QC, conducting AQ system review in compliance with CFR 21 Part 820 and developing Sop's for change control, CAPA, and management review
* Provided strategy and marketing consulting services to Maquet Intervascular
* Offered regulatory & clinical affairs consulting as well as marketing authorizations in EMEA, U.S.A., and Far-East regions
* Identified and communicated potential risks in submissions and anticipated regulatory responses
* Tracked objectives and evaluation ;
-
Maquet Intervascular
- Regulatory Advisor
2012 - 2012
on submission of a 510K.
Senior Director of Regulatory affairs
* Collaborated with the Department AQ/QC, conducting AQ system review in compliance with CFR 21 Part 820 and developing Sop's for change control, CAPA, and management review
-
Lehning
- FDA Audit Manager
2011 - 2011
* Writing SOPs (CAPA-Design Control & Design Change) to ensure full compliance with FDA CFR 21 Part 820
* Support the company during FDA audits
-
Lehning
- FDA Audit Manager
2011 - 2011
* Writing SOPs (CAPA-Design Control & Design Change) to ensure full compliance with FDA CFR 21 Part 820
* Support the company during FDA audits
-
Lehning
- FDA Audit Manager
2011 - 2011
* Writing SOPs (CAPA-Design Control & Design Change) to ensure full compliance with FDA CFR 21 Part 820
* Support the company during FDA audits
-
Boiron
- Regulatory & Quality Advisor
Sainte-Foy-lès-Lyon
2011 - 2011
* Writing strategy on pathways to MA a drug as a device
* Advise on pathways to market a drug as a device involving a strategic review of the classification of their products
-
Boiron
- Regulatory & Quality Advisor
Sainte-Foy-lès-Lyon
2011 - 2011
* Writing strategy on pathways to MA a drug as a device
* Advise on pathways to market a drug as a device involving a strategic review of the classification of their products
-
Boiron
- Regulatory & Quality Advisor
Sainte-Foy-lès-Lyon
2011 - 2011
* Writing strategy on pathways to MA a drug as a device
* Advise on pathways to market a drug as a device involving a strategic review of the classification of their products
-
Sojasun
- European Advisor
2011 - 2011
* CE Mark file writing, Pre-Clinical Support, FDA inspection CR 21 Part 820, with no major findings and just two minor findings
-
Sojasun
- European Advisor
2011 - 2011
* CE Mark file writing, Pre-Clinical Support, FDA inspection CR 21 Part 820, with no major findings and just two minor findings
-
Sojasun
- European Advisor
2011 - 2011
* CE Mark file writing, Pre-Clinical Support, FDA inspection CR 21 Part 820, with no major findings and just two minor findings
-
Bausch & Lomb
- Senior Regulatory Affairs Manager
Montpellier
2011 - 2011
* Provided strategy for submissions
* Lead the Life-Cycle Management, including renewals and variations
* Develop a Global system to speed up the renewals and variations
Pharmacovigilance Consultant
Pierre Fabre, Paris-Toulouse, France Jan 2010- April 2010
* Developing the long-term plan and infrastructure for pharmacovigilance, including systems, processes and SOPs, to facilitate full compliance with applicable laws, regulations and guidelines
* Undertaking clinical assessment of SAE cases reported from clinical trials as well as performing sponsor causality assessment and determining regulatory report ability
* Reviewing adverse event, medical history and concomitant medication coding into WHO-Drug and
MedDRA codes and reviewing aggregate safety reports for submission to domestic or international regulatory authorities as well as contributing to risk management plans
* Providing input to safety sections clinical investigator brochures, risk profiles, protocols and regulatory reports
-
Bausch & Lomb
- Senior Regulatory Affairs Manager
Montpellier
2011 - 2011
* Provided strategy for submissions
* Lead the Life-Cycle Management, including renewals and variations
* Develop a Global system to speed up the renewals and variations
Pharmacovigilance Consultant
Pierre Fabre, Paris-Toulouse, France Jan 2010- April 2010
* Developing the long-term plan and infrastructure for pharmacovigilance, including systems, processes and SOPs, to facilitate full compliance with applicable laws, regulations and guidelines
* Undertaking clinical assessment of SAE cases reported from clinical trials as well as performing sponsor causality assessment and determining regulatory report ability
* Reviewing adverse event, medical history and concomitant medication coding into WHO-Drug and
MedDRA codes and reviewing aggregate safety reports for submission to domestic or international regulatory authorities as well as contributing to risk management plans
* Providing input to safety sections clinical investigator brochures, risk profiles, protocols and regulatory reports
-
Bausch & Lomb
- Senior Regulatory Affairs Manager
Montpellier
2011 - 2011
* Provided strategy for submissions
* Lead the Life-Cycle Management, including renewals and variations
* Develop a Global system to speed up the renewals and variations
Pharmacovigilance Consultant
Pierre Fabre, Paris-Toulouse, France Jan 2010- April 2010
* Developing the long-term plan and infrastructure for pharmacovigilance, including systems, processes and SOPs, to facilitate full compliance with applicable laws, regulations and guidelines
* Undertaking clinical assessment of SAE cases reported from clinical trials as well as performing sponsor causality assessment and determining regulatory report ability
* Reviewing adverse event, medical history and concomitant medication coding into WHO-Drug and
MedDRA codes and reviewing aggregate safety reports for submission to domestic or international regulatory authorities as well as contributing to risk management plans
* Providing input to safety sections clinical investigator brochures, risk profiles, protocols and regulatory reports
-
Boston Scientific
- Xxxxx
Nanterre Cedex
2010 - 2010
* Proposed and implemented solutions to optimize Post Market operations (complaints, vigilance and customer responses) while ensuring adequate information flow within the region
-
Voisin Consulting
- EMEA Regulatory Advisor
2010 - 2010
* Gap analysis of, participation in writing, and review of the nonclinical and clinical CTD Modules
* Orphan drug designation (ODD) applications in Europe and recommendations on feasibility of ODDs
* Preparation of Briefing Packages for Scientific Advice (SA) Request/Protocol Assistance
* Participation in the preparation of Paediatric Investigation Plans (PIP)
-
Boston Scientific
- Xxxxx
Nanterre Cedex
2010 - 2010
* Proposed and implemented solutions to optimize Post Market operations (complaints, vigilance and customer responses) while ensuring adequate information flow within the region
-
Voisin Consulting
- EMEA Regulatory Advisor
2010 - 2010
* Gap analysis of, participation in writing, and review of the nonclinical and clinical CTD Modules
* Orphan drug designation (ODD) applications in Europe and recommendations on feasibility of ODDs
* Preparation of Briefing Packages for Scientific Advice (SA) Request/Protocol Assistance
* Participation in the preparation of Paediatric Investigation Plans (PIP)
-
Boston Scientific
- Xxxxx
Nanterre Cedex
2010 - 2010
* Proposed and implemented solutions to optimize Post Market operations (complaints, vigilance and customer responses) while ensuring adequate information flow within the region
-
Voisin Consulting
- EMEA Regulatory Advisor
2010 - 2010
* Gap analysis of, participation in writing, and review of the nonclinical and clinical CTD Modules
* Orphan drug designation (ODD) applications in Europe and recommendations on feasibility of ODDs
* Preparation of Briefing Packages for Scientific Advice (SA) Request/Protocol Assistance
* Participation in the preparation of Paediatric Investigation Plans (PIP)
-
Boston Scientific
- QA advisor
Nanterre Cedex
2010 - 2010
Provided strategy and marketing consulting services, including marketing authorizations in EMEA
-
Boston Scientific
- QA advisor
Nanterre Cedex
2010 - 2010
Provided strategy and marketing consulting services, including marketing authorizations in EMEA
-
Boston Scientific
- QA advisor
Nanterre Cedex
2010 - 2010
Provided strategy and marketing consulting services, including marketing authorizations in EMEA
-
Medtronic
- Regulatory Advisor
Boulogne-Billancourt
2010 - 2010
* Strategy on a warning Letter for Infuse
-
Medtronic
- Regulatory Advisor
Boulogne-Billancourt
2010 - 2010
* Strategy on a warning Letter for Infuse
-
Medtronic
- Regulatory Advisor
Boulogne-Billancourt
2010 - 2010
* Strategy on a warning Letter for Infuse
-
Wyeth
- Regulatory Advisor
2010 - 2010
* Global Coordination of an international phase II study in onco-haematology
* Coordination of the study drug supply, eCRF collection, DCF follow up, lab ranges, study document updates and follow up
-
Wyeth
- Regulatory Advisor
2010 - 2010
* Global Coordination of an international phase II study in onco-haematology
* Coordination of the study drug supply, eCRF collection, DCF follow up, lab ranges, study document updates and follow up
-
Wyeth
- Regulatory Advisor
2010 - 2010
* Global Coordination of an international phase II study in onco-haematology
* Coordination of the study drug supply, eCRF collection, DCF follow up, lab ranges, study document updates and follow up
-
Vexim SAS
- Global Head of Regulatory Affairs
2009 - 2010
* Responsible for development of regulatory strategy for a 510K study in the U.S.A. and Canada
* Organize a Registry Study for 700 patients in EMEA
Complaint and Vigilance expert
-
Vexim SAS
- Global Head of Regulatory Affairs
2009 - 2010
* Responsible for development of regulatory strategy for a 510K study in the U.S.A. and Canada
* Organize a Registry Study for 700 patients in EMEA
Complaint and Vigilance expert
-
Vexim SAS
- Global Head of Regulatory Affairs
2009 - 2010
* Responsible for development of regulatory strategy for a 510K study in the U.S.A. and Canada
* Organize a Registry Study for 700 patients in EMEA
Complaint and Vigilance expert
-
OXO
- Clinical & Regulatory Affairs Advisor
Biarritz
2009 - 2011
* Provided strategy and marketing consulting services, including marketing authorizations in EMEA, U.S.A., and Far-East regions
* Offered regulatory & clinical affairs consulting ;
* Supported and developed the outsourcing services in Regulatory and Clinical Affairs, Life Sciences
* Provided strategy and marketing consulting services, regulatory & clinical affairs consulting and marketing authorizations in EMEA, U.S.A. and Far-East regions
* Liaised with authorities, notified body and any other approving bodies delivering fast and smooth product approval and maintained international product licenses
* Identified and communicated potential risks in submissions and anticipated regulatory responses through scenario planning
* Projects included:
* Completing the following engagements: Regulatory & Clinical Advisor, Wyeth-Boston Scientific, Medtronic; Regulatory & Clinical Affairs Consultant, Voisin Consulting; Vexim SAS
* some examples of achievements:
* Vexim SAS, Balma, France ;
* Implemented SOP's for the management of clinical trials
* Responsible for development of regulatory strategy for a 510K study in the U.S.A. and Canada
* Served as a Regulatory Vigilance Officer ;
* Supervised Registrations Management of Devices in OUS ;
* Set up a Registry Study for 700 patients in EMEA ;
* Organized and led transversal meetings with R&D, Production, and AQ heads on regulatory issues ;
* Wyeth-Pharmaceuticals: Global Coordination of an international phase II study in onco-haematology (Chronic Myeloid Leukaemia): Responsible for the coordination of the study in collaboration with the team members (medical monitor, clinical scientists, data manager) as well as all the countries involved in the study (USA, Latin America, Canada, Asia Pacific and Europe; 25 countries / 90 sites) in order to conduct the study with respect of the ICH-GCP, the study plan, Wyeth SOPs and the timelines of the study
Organisation and leading of the study team meetings (global as well as regional)
Coordination of the study drug supply, eCRF collection, DCF follow up, lab ranges, study document updates and follow up
* Boston Scientific, Complaint and Vigilance expert, I identified opportunities involving Europe, Middle East and Africa countries and business units and proposed and implemented solutions to optimize Post Market operations (complaints, vigilance and customer responses) while ensuring adequate information flow within the region
* Medtronic; Within the Regulatory Affairs Europe department and in strong relation with the Emerging Markets organisation, I developed, managed and implemented policies, procedures and a system to monitor and supervise all regulatory activities in interaction with local regulatory functions for all the Business Units in Eastern Europe, Central Asia, Middle East, Africa and South Asia
* Voisin Consulting;
Gap analysis of, participation in writing, and review of the nonclinical and clinical CTD Modules
Orphan drug designation (ODD) applications in Europe and recommendations on feasibility of ODDs
Preparation of Briefing Packages for Scientific Advice (SA) Request/Protocol Assistance
Participation in the preparation of Paediatric Investigation Plans (PIP)
-
OXO
- Clinical & Regulatory Affairs Advisor
Biarritz
2009 - 2011
* Provided strategy and marketing consulting services, including marketing authorizations in EMEA, U.S.A., and Far-East regions
* Supported and developed the outsourcing services in Regulatory and Clinical Affairs, Life Sciences
* Provided strategy and marketing consulting services, regulatory & clinical affairs consulting and marketing authorizations in EMEA, U.S.A. and Far-East regions
* Liaised with authorities, notified body and any other approving bodies delivering fast and smooth product approval and maintained international product licenses
* Identified and communicated potential risks in submissions and anticipated regulatory responses through scenario planning
-
OXO
- Principal Consultant Regulatory & Clinical Operations, Life Sciences
Biarritz
2009 - 2012
* 510K and Help on Notified body certification ISO 13485-2003, Compliance CR 21 part 820
-
Liegeois Consulting Ltd.
- CEO
2009 - maintenant
Projects, responsibilities and clients have included:
-
Bausch & Lomb
- Principal Consultant
Montpellier
2009 - 2012
Regulatory & Clinical Operations, Life Sciences OXO-Consulting Pharma,
* Bausch & Lomb - Senior Regulatory Affairs Manager, Africa Region ;
* Provided strategy for submissions ;
* Lead the Life-Cycle Management, including renewals and variations
* Responsible for implementation of the Geo-Expansion strategy
* Executing development and submission strategies in EMEA region for assigned projects and assessing pros, cons and risks
Collaborating with Regulatory Strategy Leader and Regulatory Projects team leadership to ensure the alignment of development programs and product lifecycle plans
* Pierre Fabre - Pharmacovigilance Consulting ;
* Developing the long-term plan and infrastructure for pharmacovigilance, including systems, processes and SOPs, to facilitate full compliance with applicable laws, regulations and guidelines
* Undertaking clinical assessment of SAE cases reported from clinical trials as well as performing sponsor causality assessment and determining regulatory reportability
* Highlighting possible trends and concerns with company products including identifying and evaluating safety signals through assessment of single case safety reports
* Aggregating trend analyses and reviewing relevant literature for safety information
* Reviewing adverse event, medical history and concomitant medication coding into WHO-Drug and
MedDRA codes, preparing and reviewing aggregate safety reports for submission to domestic
* international regulatory authorities as well as contributing to risk management plans
Providing input to safety sections clinical investigator brochures, risk profiles, protocols and regulatory reports
* Lehning - Consulting & Support on FDA audits ;
* Writing SOPs (CAPA-Design Control & Design Change) to ensure full compliance with FDA CFR 21 Part 820 ;
* ;
* Sojasun - CE Mark file writing, Pre-Clinical Support ;
* Identifying three suppliers to perform the pre-clinical studies and writing the CE file in collaboration with the RA department
* Additionally supporting the company during an FDA inspection, with no major findings and just two minor findings
* ;
* Boiron - Consulting on pathways to MA a drug as a device
* Consulting on pathways to market a drug as a device involving a strategic review of the classification of their products ;
-
OXO
- Principal Consultant Regulatory & Clinical Operations, Life Sciences
Biarritz
2009 - 2012
* 510K and Help on Notified body certification ISO 13485-2003, Compliance CR 21 part 820
-
OXO
- Clinical & Regulatory Affairs Advisor
Biarritz
2009 - 2011
* Provided strategy and marketing consulting services, including marketing authorizations in EMEA, U.S.A., and Far-East regions
* Supported and developed the outsourcing services in Regulatory and Clinical Affairs, Life Sciences
* Provided strategy and marketing consulting services, regulatory & clinical affairs consulting and marketing authorizations in EMEA, U.S.A. and Far-East regions
* Liaised with authorities, notified body and any other approving bodies delivering fast and smooth product approval and maintained international product licenses
* Identified and communicated potential risks in submissions and anticipated regulatory responses through scenario planning
-
OXO
- Principal Consultant Regulatory & Clinical Operations, Life Sciences
Biarritz
2009 - 2012
* 510K and Help on Notified body certification ISO 13485-2003, Compliance CR 21 part 820
-
OXO
- Clinical & Regulatory Affairs Advisor
Biarritz
2009 - 2011
* Provided strategy and marketing consulting services, including marketing authorizations in EMEA, U.S.A., and Far-East regions
* Supported and developed the outsourcing services in Regulatory and Clinical Affairs, Life Sciences
* Provided strategy and marketing consulting services, regulatory & clinical affairs consulting and marketing authorizations in EMEA, U.S.A. and Far-East regions
* Liaised with authorities, notified body and any other approving bodies delivering fast and smooth product approval and maintained international product licenses
* Identified and communicated potential risks in submissions and anticipated regulatory responses through scenario planning
-
Surgical Devices
- EMEA Clinical Affairs Director
2009 - 2009
* Planning and conducting clinical trials supporting Global Clinical strategies and developing tactics for the Surgical Devices Global Business Units (GBUs) in their regional operations
* Conducting needs assessment of Medical Devices GBUs within core areas and responding to functional assignments as requested
* Ensuring the successful and timely completion of designed trials, adhering to required monitoring, study management, quality system requirements and regulatory standards and ensuring the early identification of issues
-
COVIDIEN Inc.
- EMEA Clinical Affairs Director, Surgical Devices
2009 - 2009
* Planning and conducting clinical trials supporting Global Clinical strategies and developing tactics for the Surgical Devices Global business Units (GBUs) in their regional operations
* Conducting needs assessment of Medical Devices GBUs within core areas and responding to functional assignments as requested
* Ensuring the successful and timely completion of designed trials, adhering to required monitoring, study management, quality system requirements and regulatory standards and ensuring the early identification of issues
* Managing the recruitment and selection of personnel to develop the clinical affairs department, coaching the clinical research team on operational principles and procedures and performance managing subordinates
* Creating immediate and long-range plans to facilitate the achievement of objectives for new and ongoing clinical trial research
* Accurately calculating budgets for Clinical Affairs to meet organizational goals and setting realistic overall budget schedules
* Leading the Clinical Affairs department, participating in decision making regarding department goals and building consensus for goals
* Developing and maintaining computerized data collection systems and analyzing and preparing documentation for submission to obtain clearance / approval for legal market distribution of medical devices
* Participating in scientific and medical meetings and overseeing the preparation of technical and scientific publications
* Periodically reviewing the progress of the department towards divisional and company goals and monitoring costs associated with Clinical Affairs
* Accurately interpreting and executing policies and ensuring compliance with policies and procedures
-
Surgical Devices
- EMEA Clinical Affairs Director
2009 - 2009
* Planning and conducting clinical trials supporting Global Clinical strategies and developing tactics for the Surgical Devices Global Business Units (GBUs) in their regional operations
* Conducting needs assessment of Medical Devices GBUs within core areas and responding to functional assignments as requested
* Ensuring the successful and timely completion of designed trials, adhering to required monitoring, study management, quality system requirements and regulatory standards and ensuring the early identification of issues
-
Surgical Devices
- EMEA Clinical Affairs Director
2009 - 2009
* Planning and conducting clinical trials supporting Global Clinical strategies and developing tactics for the Surgical Devices Global Business Units (GBUs) in their regional operations
* Conducting needs assessment of Medical Devices GBUs within core areas and responding to functional assignments as requested
* Ensuring the successful and timely completion of designed trials, adhering to required monitoring, study management, quality system requirements and regulatory standards and ensuring the early identification of issues
-
APTIV Solutions
- Program Director Clinical Operations
2007 - 2009
* Implemented strategies for the management of national and international clinical projects overseeing all projects and services delivery and ensured customer satisfaction
* Site Management activities include:
* Site Identification, evaluation, selection, oversight, monitoring and rating of sites, ensure site performance in line with milestones and KPI's
* Sponsor liaison and communication (Steering Committees)
* Audit preparation (Sponsor/Investigator Files
* Providing strategic regulatory medical input in the assigned therapeutic areas
-
APTIV Solutions
- Program Director Clinical Operations
2007 - 2009
* Implemented strategies for the management of national and international clinical projects overseeing all projects and services delivery and ensured customer satisfaction
* Site Management activities include:
* Site Identification, evaluation, selection, oversight, monitoring and rating of sites, ensure site performance in line with milestones and KPI's
* Sponsor liaison and communication (Steering Committees)
* Audit preparation (Sponsor/Investigator Files
* Providing strategic regulatory medical input in the assigned therapeutic areas
-
APTIV Solutions
- Program Director Clinical Operations
2007 - 2009
* Implemented strategies for the management of national and international clinical projects overseeing all projects and services delivery and ensured customer satisfaction
* Site Management activities include:
* Site Identification, evaluation, selection, oversight, monitoring and rating of sites, ensure site performance in line with milestones and KPI's
* Sponsor liaison and communication (Steering Committees)
* Audit preparation (Sponsor/Investigator Files
* Providing strategic regulatory medical input in the assigned therapeutic areas
-
APTIV Solutions
- Program Director Clinical Operations
2007 - 2009
* Implemented strategies for the management of national and international clinical projects overeeing all projects and services delivery and ensured customer satisfaction
* Led Project Managers to successful completion of projects according to corporate guidelines and sponsors' requirements
* Responsible for Medical Devices Department, providing training to the team members
* Accountable for relationships management of client accounts, ensuring delivery of projects on time and within budget by effectively managing corporate resources
* Site Management activities include:
* Site Identification, evaluation, selection, oversight, monitoring and rating of sites, ensure site performance in line with milestones and KPI's
* Management and coordination of clinical studies, preparation of status reports and study updates
* Manage the preparation and review of study documentation and ethics committee applications (Study start up activities)
* Organization of investigator meetings ;
* Training of investigational site staff and continuous site support through appropriate contingency plans ;
* KOL identification ,selection and Mapping ;
* Manage feasibility exercises, design of protocol-specific questionnaires, feasibility analysis and report generation for proposal process
* Sponsor liaison and communication (Steering Committees)
* Leading and supporting Medical Science Liaisons and Medical Information teams
* Contract negotiation and budget management ;
* Audit preparation (Sponsor/Investigator Files ;
* Provide support to other group including: Marketing, Regulatory, Market Access and Pharmacovigilance.
* Process improvement through assistance in development of SOPs in consistent with GCPs and other applicable government and regulatory agency standards
* Providing strategic regulatory medical input in the assigned therapeutic areas
* Complete Site Specific Strategies( Site Management and Developing Pt recruitment &retention strategies) ;
-
Biomimetic Therapeutics Inc.
- EMEA Clinical Affairs Director
2006 - 2007
* Conducted registration study for a combination product (MD in USA and Drug in EMEA) in 7countries (EMEA) within 15 centres on 125 patients
* Completed Study Phase II with 1 centre in Sweden with 60 patients
-
Biomimetic Therapeutics Inc.
- EMEA Clinical Affairs Director
2006 - 2007
* Conducted registration study for a combination product (MD in USA and Drug in EMEA) in 7countries (EMEA) within 15 centres on 125 patients
* Completed Study Phase II with 1 centre in Sweden with 60 patients
-
Biomimetic Therapeutics Inc.
- EMEA Clinical Affairs Director
2006 - 2007
* Conducted registration study for a combination product (MD in USA and Drug in EMEA) in 7countries (EMEA) within 15 centres on 125 patients
* Completed Study Phase II with 1 centre in Sweden with 60 patients
-
Biomimetic Therapeutics Inc.
- EMEA Clinical Affairs Director
2006 - 2007
* Conducted registration study for a combination product (MD in USA and Drug in EMEA) in 7 countries (EMEA) within 15 centers on 125 patients
* Completed Study Phase II with 1 center in Sweden with 60 patients
* Responsible for Project Management of two CROs in charge of studies
* Advisor to Board for classification of the product in EMEA ;
-
Drug International Association
- Xxxxx
2006 - 2006
* North American Spine Society, USA Since 2006
-
Biomimetic Therapeutics Inc
- EMEA Clinical Advisor
2006 - 2006
-
Drug International Association
- Xxxxx
2006 - 2006
* North American Spine Society, USA Since 2006
-
Biomimetic Therapeutics Inc
- EMEA Clinical Advisor
2006 - 2006
-
Biomimetic Therapeutics Inc
- EMEA Clinical Advisor
2006 - 2006
-
Drug International Association
- Xxxxx
2006 - 2006
* North American Spine Society, USA Since 2006
-
Gerson Lehrman Group
- Council Member
New York
2004 - 2004
* Gerson Lehrman Group (Council Member), Worldwide
-
Gerson Lehrman Group
- Council Member
New York
2004 - 2004
* Gerson Lehrman Group (Council Member), Worldwide
-
Gerson Lehrman Group
- Council Member
New York
2004 - 2004
* Gerson Lehrman Group (Council Member), Worldwide
-
AOSpine
- Xxxx
2002 - 2002
* Orthopaedic Enlightment, USA Since 1998
-
AOSpine
- Xxxx
2002 - 2002
* Orthopaedic Enlightment, USA Since 1998
-
AOSpine
- Xxxx
2002 - 2002
* Orthopaedic Enlightment, USA Since 1998
-
Rhône Alpes Chirurgie Sarl
- Owner & VP of Regulatory & Clinical Affairs
1998 - 2006
Specific Experience:
In Spine:
* Synthes-Spine (Pro-Disc) -Switzerland
* Spinal Concepts -USA
* EBI (Biomet Inc) -USA
* Interpore Cross Inc -USA
* Biomedical Enterprises Inc -USA
* Surgicraft Ltd-UK
* Cervitech Inc-USA
* LDR Spine- USA & France
* Pioneer Surgical Technologies-USA
* Biorthex-Canada
* Pearsalls-UK
* Nuvasive-USA
* VERTEBRON-USA
* ThekenDisc-USA
* Ranier Technologies-USA
* Replication Medical-USA
* Scientx-USA
In Biomaterials/Biotechnologies:
* Interpore Cross International Inc-USA (Zimmer )
* Osteotech-USA
* Apatech-UK
* Isotis Gensci-Switzerland
* Cam Implants-Holland
* Biomimetic Therapeutics Inc-USA
In Arthroplasty:
* Biopro Implants Inc-USA
* Biotechni-France
* SME (Dedienne Sante)-France
* Osteo Implants Technology-USA
* Zimmer
* Stryker
* Johnson&Johnson
In Nitinol Business:
* Biomedical Enterprises Inc-USA
* Memory Biological Applications-USA
* Biopro Implants Inc-USA
In Arthroscopy Business
* Orthomed-France
* Opus Medical Inc-US
* Assisting with internal audits and critical supplier audits, and acting as the first point of communication for on-site third-party audits and for all internal and customer-related issues
* Managing quality improvements for future ISO 13485:2003 certification, head of FDA PMA site inspections, and training staff in ISO 13485, 21CFR Part 820 and CE marking IVD Directive
* Support and organize studies for French reimbursement (TIPS)
-
Rhône Alpes Chirurgie Sarl
- Executive VP of Regulatory & Clinical Affairs
1998 - 2006
Some of my clients:
In Spine:
* Synthes-Spine (Pro-Disc) -Switzerland Spinal Concepts -USA ;
* EBI (Biomet Inc) -USA Interpore Cross Inc -USA ;
* Biomedical Enterprises Inc -USA Surgicraft Ltd-UK ;
* Cervitech Inc-USA LDR Spine- USA & France ;
* Pioneer Surgical Technologies-USA Biorthex-Canada ;
* Pearsalls-UK Nuvasive-USA
* VERTEBRON-USA Ranier Technologies-USA
* ThekenDisc-USA Replication Medical-USA
* Scientx-USA Sea-Spine (USA)
* Medtronic Inc. USA
* Alphatec (USA)
* Vexim (France)
In Biomaterials/Biotechnologies:
* Interpore Cross International Inc-USA Apatech-UK ;
* Osteotech-USA Isotis Gensci-Switzerland ;
* Cam Implants-Holland Biomimetic Therapeutics Inc-USA ;
* Medtronic USA Covidien
In Arthroplasty:
* Biopro Implants Inc-USA SME (Dedienne Sante)-France ;
* Biotechni-France Osteo Implants Technology-USA
In Nitinol Business:
* Biomedical Enterprises Inc-USA
* Memory Biological Applications-USA
* Biopro Implants Inc-USA
In Arthroscopy Business
* Orthomed-France
* Opus Medical Inc-USA
* Covidien
And my duties were:
* Set up of 2 divisions, namely Distribution of Zimmer Products in Rhone Alps and Consulting
* Served as a Regulatory and Clinical Affairs Expert for over 100 companies in the Spine, Biomaterials; Biotechnology, Arthroplasty, Nitinol Alloy, Arthroscopy arena's, IVD's, Combined Product, Biologics.
* Assisting with internal audits and critical supplier audits, and acting as the first point of communication for on-site third party audits and for all internal and customer-related issues
* Reporting on all continuous quality improvements programmes and reviewing KPIs at management review meetings, liaising with department managers for quality-related improvements
* Managing quality improvements for future ISO 13485:2003 certification, ahead of FDA PMA site inspections, and training staff in ISO 13485, 21CFR Part 820 and CE marking IVD Directive ;
* Participate in study start up consultation for studies with Latin American sites- budget, logistics- transit times (bio samples), import/export procedures and timelines
- Coordinate and plan strategy between Central Lab, Sponsor/CRO and courier (transportation kits/samples)
- Provide support via telephone and/or visits to the region(s). Train sites on lab shipping procedures, make presentations of Central lab services at Investigator Meeting
* *Provide regulatory support to proprietary drug product teams, negotiating global regulatory strategies executable within (1) Americas (Canada/Latin America/US); (2) Asia Pacific; (3) India; and (4) Europe, Middle East, and Africa regions
*Interpret global regulations to ensure regulatory compliance, assess their impact on business and product development programs, minimize product cost and reduce development cycles
* Negotiate submission data requirements and deliverable dates with regulatory authorities and internal technical teams, managing the preparation of registration packages and responses to regulatory communications
* Act as a point person for regulatory agency interactions including preparation of briefing packages and strategy for meetings, inspections, and advisory committee meetings
* Serve as primary regulatory affairs representative for prescription and generic drug products, biologics, drug delivery systems, and container/closure systems promotional and training review teams, with the responsibility of reviewing and approving regulatory content of product promotion and communication materials, including world wide web (www) content
* Serve as primary liaison to regulatory authorities regarding advertising & promotional materials - Office of Prescription Drug Promotion (OPDP) and Advertising and Promotional Labeling Branch (APLB)
* Leading a team of country RA managers within LAM organization of. Ensuring local knowledge, cultural understanding and personal contacts in emerging markets. Developing Emerging market RA strategy in cooperation with LAM regional office XXXXXXXXXXX. Executing the LAM business plan for the related RA local objectives, including partnerships. Acting as interdisciplinary focal point for the group in the area of regulatory affairs expertise and portfolio intended for LAM countries.
* Assuring the documentation and submissions of MAAs across lifecycle. Delivering timely and full approvals as well as maintaining compliance for established products.
* Support and/or drive development & clinical file content and filing strategy taking into account all aspects (CMC, non-clinical, clinical and Dx) for region for assigned project(s) in alignment with global strategy and in alignment with CMC/non-clinical and Dx teams.
* Ensure that planned Regulatory strategies meet requirements of region/country
* Primary liaison or support to liason with Regulatory Agencies/LOCs for all aspects (CMC, non-clinical, clinical and Dx).
* Support Regional Lead in Policy development and ITx input to policy & regulatory environment initiatives of GRA for Novartis Vaccines.
* Support to Regional lead as point of contact for BU, development partners, LOCs, etc. re: general topics relating to regions.
* Ensure and control that the quality level of clinical tests in subcontracted laboratories (central and research labs) is harmonized and is in line with quality requirements of the US FDA, EMEA, EU IVD, WHO, SFDA and other world regulatory bodies and/or international guidelines such as GLP, GCLP, BARQA concerning in vitro diagnostics and pharmaceutical trials.
* Make sure that compliance related documents such as SOP, working instructions, bridging reports and validation reports are available for External Partners in a controlled way and complied t
* Monitor that external laboratories meet appropriate quality, safety and regulatory standard through level 1 audit (Quality Operational management).
* Set-up, write and maintain BBT specific requirements for non-GSK laboratories (analytical Plan
* Collate and analyse performance data and charts against defined parameters (KPI)
* Coordinate the follow-up of preventive or corrective actions or deviations and are managed according in agreement with QA R&D.
* Facilitate quality improvements taking into account business
* Coordinate and follow-up the QC panel process implemented by Immunotherapeutic BU scientific experts
* Coordinating the development and implementation of the quality management system, including procedures, work instructions and forms, in compliance with the FDA 21CFR Part 820, ISO 13485:2003, and the European Union CE Marking IVD Directive
* Scientific adviser and coordinator of the research and development projects on biomaterials
(with in particular programs focused on resorbable bone substitutes, Calcium Phosphate ceramics as adequate carriers for bone cells or other osteoinductive factors, neural patches).
Elaboration of clinical studies protocols in collaboration with surgeons.
* Providing quality assurance input into device Design History Files (DHF), and reviewing all batch and DHR records for all devices, prior to release to market ;
-
Rhône Alpes Chirurgie Sarl
- Owner & VP of Regulatory & Clinical Affairs
1998 - 2006
Specific Experience:
In Spine:
* Synthes-Spine (Pro-Disc) -Switzerland
* Spinal Concepts -USA
* EBI (Biomet Inc) -USA
* Interpore Cross Inc -USA
* Biomedical Enterprises Inc -USA
* Surgicraft Ltd-UK
* Cervitech Inc-USA
* LDR Spine- USA & France
* Pioneer Surgical Technologies-USA
* Biorthex-Canada
* Pearsalls-UK
* Nuvasive-USA
* VERTEBRON-USA
* ThekenDisc-USA
* Ranier Technologies-USA
* Replication Medical-USA
* Scientx-USA
In Biomaterials/Biotechnologies:
* Interpore Cross International Inc-USA (Zimmer )
* Osteotech-USA
* Apatech-UK
* Isotis Gensci-Switzerland
* Cam Implants-Holland
* Biomimetic Therapeutics Inc-USA
In Arthroplasty:
* Biopro Implants Inc-USA
* Biotechni-France
* SME (Dedienne Sante)-France
* Osteo Implants Technology-USA
* Zimmer
* Stryker
* Johnson&Johnson
In Nitinol Business:
* Biomedical Enterprises Inc-USA
* Memory Biological Applications-USA
* Biopro Implants Inc-USA
In Arthroscopy Business
* Orthomed-France
* Opus Medical Inc-US
* Assisting with internal audits and critical supplier audits, and acting as the first point of communication for on-site third-party audits and for all internal and customer-related issues
* Managing quality improvements for future ISO 13485:2003 certification, head of FDA PMA site inspections, and training staff in ISO 13485, 21CFR Part 820 and CE marking IVD Directive
* Support and organize studies for French reimbursement (TIPS)
-
Rhône Alpes Chirurgie Sarl
- Owner & VP of Regulatory & Clinical Affairs
1998 - 2006
Specific Experience:
In Spine:
* Synthes-Spine (Pro-Disc) -Switzerland
* Spinal Concepts -USA
* EBI (Biomet Inc) -USA
* Interpore Cross Inc -USA
* Biomedical Enterprises Inc -USA
* Surgicraft Ltd-UK
* Cervitech Inc-USA
* LDR Spine- USA & France
* Pioneer Surgical Technologies-USA
* Biorthex-Canada
* Pearsalls-UK
* Nuvasive-USA
* VERTEBRON-USA
* ThekenDisc-USA
* Ranier Technologies-USA
* Replication Medical-USA
* Scientx-USA
In Biomaterials/Biotechnologies:
* Interpore Cross International Inc-USA (Zimmer )
* Osteotech-USA
* Apatech-UK
* Isotis Gensci-Switzerland
* Cam Implants-Holland
* Biomimetic Therapeutics Inc-USA
In Arthroplasty:
* Biopro Implants Inc-USA
* Biotechni-France
* SME (Dedienne Sante)-France
* Osteo Implants Technology-USA
* Zimmer
* Stryker
* Johnson&Johnson
In Nitinol Business:
* Biomedical Enterprises Inc-USA
* Memory Biological Applications-USA
* Biopro Implants Inc-USA
In Arthroscopy Business
* Orthomed-France
* Opus Medical Inc-US
* Assisting with internal audits and critical supplier audits, and acting as the first point of communication for on-site third-party audits and for all internal and customer-related issues
* Managing quality improvements for future ISO 13485:2003 certification, head of FDA PMA site inspections, and training staff in ISO 13485, 21CFR Part 820 and CE marking IVD Directive
* Support and organize studies for French reimbursement (TIPS)
-
BIOTECH INTERNATIONAL SA
- General Manager
1997 - 1998
* Implemented ISO 9001 and EN 46001 ;
* Set up two subsidiaries for dental implants in India and Brazil ;
* Developed university courses on implantology in India (with Hospital Cochin-Paris) ;
* Managed international development of brand products in Asia, South America, U.S.A., and Europe ;
-
BIOTECH INTERNATIONAL SA
- General Manager
1997 - 1998
* Implemented ISO 9001 and EN 46001
* Set up two subsidiaries for dental implants in India and Brazil
* Developed university courses on implantology in India (with Hospital Cochin-Paris)
* Managed international development of brand products in Asia, South America, U.S.A., and Europe
* Bring the company from 12k FF to 147k FFin about a year
-
BIOTECH INTERNATIONAL SA
- General Manager
1997 - 1998
* Implemented ISO 9001 and EN 46001
* Set up two subsidiaries for dental implants in India and Brazil
* Developed university courses on implantology in India (with Hospital Cochin-Paris)
* Managed international development of brand products in Asia, South America, U.S.A., and Europe
* Bring the company from 12k FF to 147k FFin about a year
-
BIOTECH INTERNATIONAL SA
- General Manager
1997 - 1998
* Implemented ISO 9001 and EN 46001
* Set up two subsidiaries for dental implants in India and Brazil
* Developed university courses on implantology in India (with Hospital Cochin-Paris)
* Managed international development of brand products in Asia, South America, U.S.A., and Europe
* Bring the company from 12k FF to 147k FFin about a year
-
Stryker
- Surgical Advisor
Pusignan
1994 - 1996
-
Stryker
- Surgical Advisor
Pusignan
1994 - 1996
-
Stryker
- Surgical Advisor
Pusignan
1994 - 1996
-
Stryker
- Surgical Advisor
Pusignan
1994 - 1996
-
Arthroplasty and Spine
- Surgical Advisor
1993 - 1994
-
Zimmer
- Surgical Advisor
1993 - 1994
-
Arthroplasty and Spine
- Surgical Advisor
1993 - 1994
-
Arthroplasty and Spine
- Surgical Advisor
1993 - 1994
-
Arthroplasty and Arthroscopy
- Surgical Advisor
1989 - 1992
for Arthroplasty and Arthroscopy
Depuy Orthopaedics
Technical skills
Software Extedo, ArtsGlobal, Trackwise, Liquent
CFR21 Part 820, CFR21 Part 11, ISO 13485-2016
GCP, GLP, GMP
PROFESSIONAL MEMBERSHIPS ,
-
Arthroplasty and Arthroscopy
- Surgical Advisor
1989 - 1992
for Arthroplasty and Arthroscopy
Depuy Orthopaedics
Technical skills
Software Extedo, ArtsGlobal, Trackwise, Liquent
CFR21 Part 820, CFR21 Part 11, ISO 13485-2016
GCP, GLP, GMP
PROFESSIONAL MEMBERSHIPS ,
-
Depuy Orthopaedics
- BENELUX EXPERT
1989 - 1992
-
Arthroplasty and Arthroscopy
- Surgical Advisor
1989 - 1992
for Arthroplasty and Arthroscopy
Depuy Orthopaedics
Technical skills
Software Extedo, ArtsGlobal, Trackwise, Liquent
CFR21 Part 820, CFR21 Part 11, ISO 13485-2016
GCP, GLP, GMP
PROFESSIONAL MEMBERSHIPS ,
