Mary McNamara-Cullinane

Mary McNamara-Cullinane has over 25 years of regulatory experience in the medical device, diagnostics and biotech industries. She has successfully authored over 170 510(k)s, multiple PMAs, two De Novo submissions and has been responsible for several clinical trials. In addition, she has strong regulatory knowledge of global regulatory practices and registrations in Europe, Korea, and Australia having work on many technical files and CERs. Most recently, Mary was responsible for US regulatorystrategy at Intrinsic Therapeutics, VP of Regulatory and Clinical Affairs at Echo Therapeutics, Director of Regulatory Affairs at Z-Medica, and Director of Regulatory Affairs and Quality Assurance at Molecular Biometrics.Prior to Molecular Biometrics, Mary was in regulatory consulting for 17 years at Medical Device Consultants, Inc.