Sheila Hemeon-Heyer

Sheila Hemeon-Heyer joined PathMaker Neurosystems in February 2015 and is responsible for assuring compliance with worldwide regulatory requirements governing PathMaker medical devices. Sheila brings 28 years of regulatory experience to PathMaker, beginning as a Scientific Reviewer in the Office of Device Evaluation at the US Food and Drug Administration. After leaving FDA, Sheila joined Medical Device Consultants, Inc. as a Senior Consultant and Director of Regulatory Services, leading premarket regulatory, postmarket quality, and clinical study projects for a wide variety of medical device technologies and combination products. Sheila joined Boston Scientific Corporation in April, 2005 as Vice President, Global Regulatory Affairs, where she was responsible for worldwide regulatory strategies, operations and intelligence. Most recently, Sheila founded Heyer Regulatory Solutions LLC, providing global regulatory submission, clinical, and compliance consulting services to the medical device industry. She holds a B.S. in Biomedical Engineering from Boston University, an M.S. in Biomechanics from the University of Massachusetts at Amherst, a J.D. from Western New England College School of Law, is US and EU Regulatory Affairs Certified, and is a Fellow of the Regulatory Affairs Professional Society. Sheila currently serves as the Chair of the Food and Drug Law Institute (FDLI) Board of Directors.