Mes compétences :
Affaires réglementaires
Dispositifs médicaux
Médical
Medical device
Regulatory Affairs
Equipements Electriques
Marquage CE
Entreprises
Millipore
- Regulatory Affairs specialist
Guyancourt2012 - maintenant- Develop regulatory strategies in support of marketing plans for new products and introduction into global markets. Provide support and guidance to identify regulatory requirements during new product development process. Ensure the design plan for new products or services complies with corporate guidelines for submission and meets government standards.
- Make sure the company strictly follows government rules and regulations relevant to company goals and operations. Provide feedback on pertinent issues and defend the company’s interests and positions.
- Establish and maintain the regulations and standards applicable to product portfolio and to their global distribution. Assure a regulatory watch on the applicable standards concerning finished products and componants (vendor). Develop a process to evaluate the impact of standard evolution to product and process. Review change request and complaints on regulated products.
- Regulatory focal contact point for R&D,Production ,QA ,Marketting and Sales support for advise,consulting ,information finding. Help for making decision. Involve extensive interaction with regional and national regulatory agencies. “Materiovigilance” contact.
- Review and approve all applicable labelling.
GE Healthcare
- Regulatory Affairs leader
2006 - 2012- Safety and Regulatory engineer, responsible for new product design inputs related to safety regulatory requirements for Diagnostic Imaging medical devices. Develop required documentation for FDA premarket notification submissions, CE Declaration of Conformity, and Technical Files.
- Product Surveillance leader, responsible for evaluation of issues identified on existing products, investigate and document Risk Assessments, and make USA reporting decisions.
- Participate in and assists with FDA facility inspections, Notified Body Audits and other governmental inspections.
- Perform team coaching, presentation and training for Safety and Regulatory matters. Support engineering team for applicability of Risk Assessment and Control Documents. Lead local Safety and Regulatory strategy.
Plaisir2001 - 2006- Team and projects management (10 persons)
- Continuous improvement of testing process and equipments
- Partial outsourcing of validation activities
Maquet
- Validation Manager
ARDON1998 - 2001- Team and projects management (5 persons)
- Development and implementation of validation plans and testing tools
Environement SA
- Program Manager
1992 - 1998- Automotive pollution control projects management
- Responsible for Air Analyzers approvals
Millipore
- Research & Development Engineer
Guyancourt1990 - 1992- Research and development of laboratory filtration products
- Implementation of new Computerized Assisted Drawing stations
SOPRA SA
- Field Engineer
Paris1984 - 1990Responsible for installation and service of measurement and analysis systems
