Head of Regulatory, AM & D

Head of Regulatory, AM & D

Head of Regulatory for Ambulatory Monitoring & Diagnostics will develop and execute global regulatory strategies aligned with business objectives, serving as the primary liaison between regulatory authorities and internal stakeholders while ensuring regulatory compliance across product development and commercialization. The role leads a team of Regulatory Affairs specialists, mitigates regulatory risks, oversees submissions and filings, and drives cross-functional integration of evolving global regulatory requirements.

You're the right fit if:

• You’ve acquired 8+ years of experience with Bachelor’s, or 6+ years with master’s degree in Regulatory Affairs in the medical device industry. People leader experience is a must. Experience authoring class 2 510k submissions is a must, cardiology experience is preferred.