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Sorin
- Regulatory Affairs Leader - CE
Paris
2013 - maintenant
- Coordinating CE marking for all Sorin CRM products (active implantable devices pacemakers, defibrillators), combined medical devices, Class IIa/IIb):
Interactions with the Notified Body
Submissions planning
Harmonization of technical files preparation
Implementation of CE marking processes
- Preparation of technical files for CE marking
- Participation in audits/inspections (ISO 13485, China CQC audit, FDA)
- RA representative in new products development projects
- Regulatory & standards watch
- Project leader of RoHS regulation implementation
Quality Assurance:
- ISO 13485 (2003) Certified
- Ongoing qualification to become Internal auditor
- Participation in several audits & inspections (China, FDA, ISO 13485…) as part of the support team. Participation in the preparation phases and in post audits (non conformities management)
- Internal audits
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MATIS Group
- Regulatory Affairs consultant - Export - Sorin CRM
Boulogne-Billancourt
2011 - 2012
- Registration of active implantable devices in China: submissions planning, local testing preparation & management, submission files preparation
- Active implantable devices & class IIa devices (holters) registration in different countries (Israel, Hong Kong, Russia, Australia…)
- Regulatory Affairs representative in project team for the e-labeling regulation implementation
- RA representative in new product development projects
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MATIS Group
- Regulatory Affairs Consultant - GE Healthcare
Boulogne-Billancourt
2010 - 2011
- Mammography devices & software registration in China: submission planning, testing preparation, submission files preparation
- Implementation of manufacturing processes regarding CCC conformity (China)
- Registration & renewals of mammography devices in different countries
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LFB Biomédicaments
- Regulatory & standards watch internship
LES ULIS
2009 - 2009
- Regulatory & standards watch on Good Manufacturing Practices Class I/IIa devices (France, Europe, USA), preparation and distribution of a Watch Bulletin
- Implementation of a regulatory watch database
- Implementation of a standards database and associated process
