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Medtronic
- Regulatory Affairs Product Specialist, Regulatory Affairs Department
Boulogne-Billancourt
2014 - maintenant
• Generate technical files (class IIb and III) with the STeD format
• Prepare 510(k), CE Marking file and other related regulatory filings to support registrations in USA, Europe, Australia and Canada
• Support to worldwide registrations
• Act as a Regulatory Affairs Core Team Member for several projects:
- Definition, Documentation and Implementation of regulatory strategies for new technologies, new products
- Provide regulatory support to design teams
- Review of preclinical and clinical strategies to ensure the regulatory conformance
- Review and Approval of the documentation proving the product conformity and supporting the regulatory submissions
- Interface with R&D, Clinical, Quality, Manufacturing, Marketing, and Sales staff
• Approval of Labeling
• Regulatory monitoring and Information to the management and concerned departments
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Johnson & Johnson - DePuySynthes
- Regulatory Affairs Associate, Regulatory Affairs Department
2012 - 2014
- Creation and Update of Technical File (DM: class I, IIa, IIb and III) for the CE marking
- Knowledge of STeD format
- Review and Approval of the documentation which demonstrates the compliance with the essential requirements
- Follow-up of export requests to support the registrations in other countries
- Implementation of French, European and American regulatory requirements
- Regulatory monitoring
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TBF Génie tissulaire
- Trainee, Regulatory Affairs, Regulatory Affairs Department
2011 - 2011
- Creation of the Module 3 of the CTD for the certification of an ATMP (Advanced Therapeutic Medicinal Product) y the EMA
- Implementation of ICH Q9 and ISO 14971 in the risk management system
- Creation of risk analysis
- Regulatory monitoring
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BioMérieux S.A., site de Grenoble
- Trainee, Quality Assurance, QMS Department
2009 - 2009
- Implementation of quality procedures following a manufacturing transfer
