Mary McNamara-Cullinane joins Alira Health

Boston, MA – Alira Health is pleased to announce that Mary McNamara-Cullinane, RAC has joined the firm as a Partner, bringing her extensive expertise in Regulatory Consulting to Alira Health’s clients worldwide. Mary has authored over 180 510k submissions and was involved with 3 PMA approvals. In addition, she has submitted over 50 Pre-Submissions, Requests for Designation, 513(g) Requests for Classification and one Reclassification Petition.
“I am thrilled to join the Alira Health team.  I was attracted by the company’s mission of strategy, execution, and innovation to the life science and healthcare sectors by providing real-world experience,” said Mary McNamara-Cullinane. “I intend to apply my long-term experience and expertise in medical device, diagnostic and combination products to provide regulatory strategy and submission execution for optimal client success.”
Mary can bring over 25 years of regulatory strategy and submission execution across an extensive scope of therapeutic areas including digital, general and plastic surgery, wound care, physical medicine, dental, radiology, cardiology, and neurology.

“Mary has a deep and extensive knowledge not only in developing appropriate regulatory strategies for our clients but also in translating the strategy into skillfully written and well-organized submission to regulatory agencies,” said Dr. Giacomo Basadonna, Managing Director of Global Medical Affairs at Alira Health. “She has a unique and impressive ability to tackle complex regulatory challenges, being able to develop successful approaches to complicated situations. She is brilliant in face-to-face meetings with clients, making them feel comfortable with her preparation, vast experience and extensive personal knowledge”

In addition, Mary has unique and extensive experience in negotiating difficult and challenging pathways through the FDA including but not limited to denovos, RFD’s, 513gs, 510ks, PMA’s labeling and marketing claims.

Partner, United States

Mary McNamara-Cullinane is a regulatory expert bringing over 25 years of regulatory experience to Alira Health. Prior to joining Alira Health, Mary has had her own consulting firm since 2011 (MMC Regulatory Consulting).  Mary worked as  Senior Regulatory Consultant to MEDIcept, as Senior Director of Regulatory Affairs for Intrinsic Therapeutics, and held executive positions in Regulatory Affairs for Echo Therapeutics, Z-Medica Corporation, Molecular Biometrics, and Medical Device Consultants. Earlier in her career, she was a scientist at Hygeia Sciences (acquired by Carter-Wallace).  Mary McNamara-Cullinane has over 25 years of regulatory experience in the medical device, diagnostics, combination product and biotech industries. She has successfully authored over 175 510(k)s, multiple PMAs, denovo submissions, requests for classification and designations submissions as well as been responsible for several clinical trials.  Mary has focused on helping emerging companies navigate challenges during development while establishing appropriate clinical, regulatory, and compliance pathways.

Mary has a BA in Biology from Mass College of Liberal Arts, with concentrations in Molecular Biology and Medical Technology.  She did post graduate studies at Northeastern University in Cardiovascular Health and Exercise Science.  She is Regulatory Affairs Certified and has written extensively for various industry journals and newsletters on a broad range of topics related to regulatory affairs.

To learn more about Mary McNamara-Cullinane and the rest of our team, visit