The Company is seeking a Vice President of Global Regulatory Affairs to lead the development and execution of a comprehensive regulatory strategy for its complex surgical robotics portfolio, with a focus on oncology applications. The successful candidate will be responsible for both strategic and operational regulatory initiatives, including driving regulatory submissions and approvals, global market entry, and post-market compliance. This role requires a proven track record in guiding cross-functional teams to regulatory success in multiple global jurisdictions, as well as a deep understanding of FDA regulations, ISO standards, and EU MDR. The ideal candidate will have at least 20 years' of progressive regulatory affairs experience in the medical device industry, with a strong background in complex device ecosystems and experience in robotic-assisted surgical devices. Key responsibilities for the Vice President of Global Regulatory Affairs include developing and maintaining an agile global regulatory infrastructure, overseeing US and global regulatory strategies, and providing expert guidance on regulatory pathways for new technologies and oncology-related device submissions. The role also involves cross-functional collaboration, team development, and management, and ensuring global compliance with regulatory standards. The candidate should be a recognized leader in the regulatory community, with a network of industry and agency contacts, and possess exceptional team-building abilities. A BS/BA in a relevant scientific, engineering, or medical discipline is required, with an advanced degree strongly preferred. The role demands a leader who is adept at balancing risk management with the need for timely and innovative product development, and who can influence stakeholders at all levels.

Hiring Company

PROCEPT BioRobotics