BioMérieux SA - Grenoble
- Responsable SMQ et Assurance Qualité Fournisseurs
2013 - maintenant
BioMérieux SA
- Senior Regulatory Affairs Specialist
MARCY-L'ETOILE2008 - 2013Specialist for IVDs in the field of Molecular Biology
• RA representative in project teams for Molecular Biology IVDs and instrument/software medical devices developments (different ranges, different platforms)
• RA representative for manufacturing transfer projects (strong interfaces with Supply Chain, manufacturing operations, Marketing, Labeling Dept.)
• RA representative for the integration of an acquired company (strong interfaces with Marketing, Quality, Site management)
• Management of the regulatory activities for a whole range of molecular products between different sites (design changes, on-conformity review board, post-market surveillance committee)
• Regulatory strategies for products launch in collaboration with local representatives
• Placing on the market in-vitro diagnostics devices in Europe (CE marking incl. Annex II products) and outside Europe countries
• Registration renewals and support for international registrations (e.g. Canada, Australia, China, India, Japan, South America, etc.)
• Direct relations with Notify Body and Competent Authorities
• Labeling and promotional documentation approval
• Training to regulatory requirements and companionship for new comers
BioMérieux SA
- Regulatory Affairs Specialist
MARCY-L'ETOILE2005 - 2008 • RA representative in project teams for Bacteriology and microbiology control IVD devices product developments
• Launch and placing on the market in-vitro diagnostics devices in Europe (CE-marking), international registrations
• Regulatory representative for design changes, non-conformity review board, post-market surveillance committee
• Labeling and promotional documentation approvals
