Senior Vice President, Regulatory Affairs

Mary McNamara-Cullinane

Boston, USA

Mary is an accomplished and experienced regulatory professional, drawing on 25 years of experience in the healthcare and life sciences field. Mary’s clearances include: 510k (abbreviated and special), PMA approvals, IDE approvals, De Novo, 510k submissions for novel medical devices, and 513g requests for classifications. Mary is also a frequent conference speaker and panelist on a range of topics including MedTech, regulatory affairs, and women in healthcare.


Speaking engagements icon
of speaking engagements
Years in industry icon
of years in the industry
of submissions

Key areas of expertise

  • Regulatory Strategy & Roadmap Development
  • Submission Management
  • FDA U.S. Agent
  • Combination Products
  • Digital Health

Languages spoken

United Kingdom flag icon English
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