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
15
of speaking engagements
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
English
Mary's recent publications