Over 30 years of experience in the medical device industry, both at industry-leading corporations and small business start-ups. Her background includes all aspects of domestic and international medical device regulatory and quality management for a wide range of products including cardiovascular, orthopedic, electromedical devices, nuclear medicine and in vitro diagnostics (IVD). She has authored numerous successful 510(k)’s, original PMAs, PMA Supplements, technical files and design dossiers. She received her Bachelor of Science degree from the University of New York (Regents College) and is a member of the Regulatory Affairs Professionals Society.