Ms. Flégeau began working in regulatory affairs while living in Paris, France. She has spent over 20 years in the medical device field working in diverse international companies both small and
large, focusing on a variety of medical devices such as cardiac, orthopedics, catheters, active implantable devices…etc. She is an expert in CE marking, FDA submissions and international
registrations. Her expertise includes regulatory strategies, submissions, technical files and creative problem solving.
Ms. Flégeau has worked directly with regulatory agencies in Canada, EU, China, Japan, Korea, France, and Brazil.
Ms. Flégeau holds a BA in International Business from Illinois Wesleyan University, and a Leadership Certificate from Kellogg School of Management. She is fluent in French.
Ms. Flégeau oversees the Florida chapter of the Regulatory Affairs Professional Society (RAPS). She currently is Associate Director of Regulatory Affairs at Johnson and Johnson – Sterilmed division.