Mark D. Kramer, RAC is the President of Regulatory Strategies, Inc. He began his career in engineering and clinical/regulatory affairs positions at Cordis Corporation. Mark joined the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) as a scientific reviewer in the Pacing and Electrophysiology Devices Branch, and then served as Chief of the Urology and Lithotripsy Devices Branch. He next went to the private sector, serving in both consulting and in-house corporate regulatory affairs capacities. Mark returned to FDA as Chief of CDRH's Anesthesiology and Defibrillator Devices Branch until his appointment as Director, CDRH Staff College. He served as Director of FDA's Combination Products Program from February 2002 until he established the Office of Combination Products in December 2002, where he served as Director until April 2007. As OCP Director, Mark led the development of policies, procedures and processes to facilitate the assignment, premarket review and postmarket regulation of combination products. From April 2007 through July 2010, Mark was Vice President, Regulatory Affairs at GE Healthcare, where he had executive responsibility for US, Canadian and Latin American regulatory affairs. Detailed Professional Experience/CV
Mark served on the Board of Directors of the Regulatory Affairs Professional Society (RAPS) from 2009-2014, and he was the founder and Chair of the Wisconsin RAPS Chapter. He is an adjunct faculty member in the Department of Regulatory Affairs at St. Cloud State University in Minnesota. He holds an M.S. in Biomedical Engineering from Rensselaer Polytechnic Institute and is Regulatory Affairs Certified (RAC). Mark was named one of the 100 Notable People in the Medical Device Industry by MD&DI Magazine and is a member of the FDA Alumni Association.