Roland Gerard is a Regulatory Affairs Expert with 30 years of experience in the field of high risk implantable medical devices: he has worked for the European Committee for Standardization (CEN), Intermedics and more recently for St. Jude Medical, where he occupied the position of Vice President RA/QA in the International Division.

During all those years, he has developed an in-depth knowledge of EU Medical Device Directives and Environment Legislation as well as standards and quality management system (ISO 13485) implementation and certification. He also has extensive experience in CE marking and in dealing with competent Authorities and Notified Bodies.