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Cardinal_Health
- Medical Products Quality Assurance and Regulatory Affairs Manager (France, UK, Ireland & Benelux)
Cergy Pontoise Cedex
2016 - maintenant
Develop and execute quality and regulatory processes (ISO 13485)
Guarantee that regulatory requirements are met in regards to local and national laws and company
standards in order to place and/or maintain products on the markets
Act as Local Safety Officer for the local authorities
Develop and implement regulatory strategies and processes to assure timely commercialization of
products in compliance with applicable regulations and standards in country
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Johnson & Johnson
- EMEA Quality and Regulatory Affairs Manager
New Brunswick
2015 - 2015
ISO 13485 QMS (Internal/External Audits & Inspections, CAPA, Management Reviews, etc..)
Ensure regulatory compliance for Medical Devices: Health Authorities communication, Market access, etc..
Quality & Regulatory support for Business, Sales & Marketing departments
Marketing & Sales teams training
Regulatory Intelligence (involvement on internal and external working groups, Trade Associations)
Complaints handling and Field Actions Management
Lead and Support EMEA Life Cycle Management projects
Participation to direct customer input activities in EMEA (VOC, customer visits, congresses, etc..)
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Johnson & Johnson
- Quality and Regulatory Affairs Manager
New Brunswick
2011 - 2015
ISO 13485 QMS (Internal/External Audits & Inspections, CAPA, Management Reviews, etc..)
Ensure regulatory compliance for Medical Devices: Health Authorities communication, Market access, etc..
Quality & Regulatory support for Business, Sales & Marketing departments
Marketing & Sales teams training
Regulatory Intelligence (involvement on internal and external working groups, Trade Associations)
Complaints handling and Field Actions Management
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Johnson & Johnson
- Medical Devices Vigilance Officer
New Brunswick
2010 - 2011
Incidents supervising and risk assessment associated with the use of Medical Devices
Data collection, investigation, documentation of cases
Supervising expertise results and writing MEDDEV final report,
Reporting of serious incidents and expertise results to ANSM,
Regulatory support in Vigilance for marketing departments, medical devices representatives, HE&R department, Customers department
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APHP Hôpital Paul Brousse
- Responsible for an epidemiological study (four months training courses)
2010 - 2010
Management of an epidemiological study on patients under chemotherapy at the paul Brousse hospital
