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.

Highlights

Speaking engagements icon
15
of speaking engagements
Years in industry icon
25+
of years in the industry
200+
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

Our locations around the globe

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