Manager of the RA/QA Department – Roland Gerard
Roland Gerard is a regulatory affairs expert with 30 years of experience in the field of high risk implantable medical devices. Roland 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, has extensive experience in CE marking and in dealing with competent Authorities and Notified Bodies, has experience in working with senior management to support business needs, speed up market access and manage crises.
Mr. Gerard has been a member of GHTF study group 2, GHTF Steering Committee, President of RAPS Europe, President of IAPM, Chair of the Regulatory Affairs Committee of IAPM and more recently Chair of the Regulatory Affairs Committee of EUCOMED. He has been involved in numerous conferences as a speaker as well as in the development of the new Medical Devices Regulation.