Head of Regulatory, AM & D
$171,000–$273,000 year
On-siteChicago, Illinois, United States or Cambridge, Massachusetts, United States
Job Summary
Develop and execute global regulatory strategies aligned with business objectives, serving as the primary liaison between regulatory authorities and internal stakeholders. Lead a team of Regulatory Affairs specialists, driving talent development, succession planning, and performance management to ensure regulatory excellence. Oversee global product registrations, approvals, CE Marking, clinical evaluations, and regulatory submissions to ensure timely commercialization and sustained compliance in international markets. Act as the primary representative to regulatory authorities and industry organizations, building strong relationships and influencing policy discussions while integrating regulatory requirements into product development and business processes. Requires 8+ years of experience in medical device regulatory affairs with people leader skills and Class II 510(k) submission expertise. Full-time office-based role in Chicago, IL, Malvern, PA, or Cambridge, MA with up to 15% travel.
Required Qualifications
- 8+ years of experience with Bachelor's degree in Regulatory Affairs in the medical device industry
- 6+ years of experience with master's degree in Regulatory Affairs in the medical device industry
- People leader experience
- Experience authoring class 2 510k submissions
- Proven ability to represent a medical device company with competent authorities during audits and for responses
- Experience with both new product development and sustaining activities
- Bachelor's/master's degree in biomedical engineering, Business Administration, Health Sciences, Pharmaceutical, Law or Equivalent
- Strong knowledge of relevant regulations and standards (ISO 13485, 14971, etc.)
- Ability to influence cross-functional stakeholders utilizing clinical expertise and knowledge of standard of care and medical device standards
- Must be willing and able to travel up to 15% as required by business needs
- US work authorization
- Reside in or within commuting distance to posted locations (Chicago, IL, Malvern, PA, or Cambridge, MA)
Desired Qualifications
- Cardiology experience
- RAC certification
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