Following college graduation, Gaëlle spent five years at a University Hospital before joining NAMSA in 2001. During her career at NAMSA, she has progressed from Study Director, Laboratory Scientific Director and now to her current role as Preclinical Specialist within the Product Development Strategy group. Gaëlle works with a wide range of medical device companies supporting their development and regulatory strategies.
- Designs, develops and executes regulatory compliant preclinical strategies for multiple innovative devices
- Develops protocols for preclinical evaluation of safety and performance of innovative devices based on state-of-the-art scientific and regulatory requirements
- Supports the development of complex preclinical models in collaboration with NAMSA worldwide laboratories
- Conducts Gap Analyses of biocompatibility and preclinical data
- Contributes to interactions with global regulatory agencies
- Supports FDA pre-submissions meetings related to preclinical strategies
- Supports multiple manufacturers, addressing challenges with regulatory bodies in liaison with preclinical strategies/models
- Oversees strategy execution in the laboratories and participates in problem solving in case of technical and scientific questions
- Developed and executed the biocompatibility and preclinical strategy for U.S. and EU market access of an innovative, degradable hemostatic polymer-based device in multiple indications; successful outcome with ongoing clinical trials in EU and U.S.
- Developed preclinical protocols for evaluation of safety and performance of several devices for FDA pre-submissions (510K, De novo, PMA) including brain implants, blood filtration systems, glucose monitoring systems, dermal fillers and orthopedic/ dental devices; obtained FDA approval of strategy prior to study execution
- Developed the biocompatibility and preclinical strategy for evaluation of the safety of a nanoparticle-based blood filtration system; discussions with BfArM and FDA for initiation of clinical trials
- Supported CE-marking of an innovative magnesium-based dental device