Director of Regulatory Affairs
Pam Papineau has over 30 years’ experience in quality and regulatory affairs with Baxter, Boston Scientific and Cogentix (Vision-Sciences), and has served as a consultant on a wide variety of devices that includes endoscopy, imaging, GI/GU, orthopedic and cardiovascular. Pam has successfully prepared dozens of FDA pre-market submissions and European Union (EU) technical files to support CE marking of a broad spectrum of medical devices, and has overseen numerous clinical studies entailing protocol development, reporting and management of Clinical Research Organization (CRO) services. Pam is an ASQ Certified Quality Engineer (CQE), a Certified Quality Auditor (CQA), a Certified Biomedical Auditor (CBA), an ISO 13485:2016 Lead Auditor, and holds Regulatory Affairs Professional Society (RAPS) certifications for the US, EU, CAN. Pam will work with Hogan & Lovells, the Company’s legal Counsel, to prepare for a pre-submission meeting with the FDA and follow-on activities through the regulatory approval process.