Mary joined ClearPoint Neuro in August 2022. She has over 25 years of regulatory experience in the medical device, diagnostics, and biotech industries. She has successfully authored over 170 510(k)s/responses, multiple PMAs, De Novo submissions, Breakthrough device designations, 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 worked on many technical files and CERs. Most recently, Mary was Senior Vice President of Regulatory at Alira Health responsible for management of all medical device/combination product strategies, submissions, and FDA meetings. Prior to that position, she was responsible for US regulatory strategy at Intrinsic Therapeutics, VP of Regulatory & Clinical Affairs at Echo Therapeutics, Director of Regulatory Affairs at Z-Medica, and Director of Regulatory Affairs & Quality Assurance at Molecular Biometrics. Before her time at Molecular Biometrics, Mary was in regulatory consulting for 17 years at Medical Device Consultants, Inc.
Vice President of Regulatory Affairs