Greater Grenoble Metropolitan Area
Contribute to restore patients’ lifestyles through regulatory in orthopedics and ensure safe and performant devices. Drive regulatory team and develop business partnering to support business and maintain compliance with regulation continuously strengthened. Continuous improvement to gain efficiency, take up challenges and accompany changes in a dynamic sector and company.
Management of Regulatory Affairs department in charge of Europe, US and Canada. Medical devices: Orthopedic implants (IIb, III), associated instrumentation and surgery planning software. Drive submission and regulatory strategies all over product lifecycle to support business needs. Key player in product risk management, Clinical evaluation and PMS. Provide technical leadership and vision. Develops and influences global regulatory policy. In charge of site regulatory compliance and support company changes. Core team member for transition to MDR.
Management of Regulatory Affairs department in charge of regulatory registrations in countries out of Europe and North America: Japan, Australia, China, Brazil and more than 15 countries in Asia, Latin Ameria and Middle East. Planning, regulatory strategy , relation with marketing and sales, internal business partnering and international coordination to meet regulatory requirements and support business needs. Audits and inspections support. Until 2015: Vigilance correspondant in charge of vigilance and FSCA activities, relations with Authorities, process development
EC marking and 510(k) technical files for orthopedic medical devices (prostheses and instrumentation). Participation to new products development projects. Vigilance: communication with the Afssaps and foreign agencies, files management, SOP Regulatory intelligence
European project Nanosafe2 in the Tracer Technology Lab (L2T) at the CEA Grenoble. Research groups about safe production and use of nanoparticles, in particular, prevention and detection of nanoparticles.
Contract between Eurotungstene Metal Powder and the CEA Grenoble - LT2N (Lab for Nanopowders and Nanocomposites Technology) Study of a new metal powder process by milling. Evaluation of the project feasibility on the industrial scale : - bibliography - process developpment - testing campains (milling, mechanical tests) - financial appraisal
GPM2 lab (Physics Engineering and Materials' Mechanics) Study of the Liquid Metal Embrittlement of aluminum by mercury Preliminary studies of the project : bibliography, test settling