Senior Consultant
Cécile is a Senior Consultant in Regulatory Affairs at Qserve with over 20 years of experience in Quality and Regulatory Affairs in the medical devices industry.
She started her career as a test engineer and Quality auditor for a certification body before working in Quality and Regulatory Affairs for different manufacturers of both active and non active devices, from class I to class III. She has worked in both post-market (complaint handling, vigilance reporting, FSCA) and pre-market (CE marking technical documentation, Notified Body contact person, EMEA registrations). In the last years she was involved in the MDR certification project, establishing the regulatory strategy and planification with the Notified Body, leading the team in charge of updating the technical documentation, managing the technical file submission and subsequent Q&A with the Notified Body and the MDR initial certification audit.
Cécile holds a Msc in biology with a specialty in biomaterials and biomechanics from University of Technology of Compiègne (France).