Vice President, Global Regulatory Affairs

Job description

Job responsibilities

• Directly supervises employees in the Regulatory Affairs Department in accordance with PROCEPT BioRobotics’ policies and applicable laws.
• Interviewing, hiring, and training employees
• Planning, assigning, and directing work
• Appraising performance; rewarding and disciplining employees
• Addressing complaints and resolving problems

Job requirements

• BS/BA in a relevant scientific, engineering, or medical discipline; advanced degree (MS, PhD, or equivalent) strongly preferred.
• Minimum 20+ years of progressive regulatory affairs experience in the medical device industry, with at least 2 years in a VP or equivalent senior leadership role.
• Demonstrated excellence in managing complex regulatory submissions and approvals (e.g., for advanced surgical robotics (with AI/ML referred) and/or oncology-related devices);
• Outstanding writing and communication skills, evidenced by successful authorship of critical regulatory submissions, briefing documents, and formal responses
• Proven history of collaborating with clinical teams, including oversight of IDEs or clinical trials supporting oncology-focused regulatory filings; prostate cancer experience is highly desirable
• Track record of on-boarding different or emerging technologies into an existing portfolio and expediting their path to market
• A recognized leader in the regulatory community, with a network of industry and agency contacts
• Deep understanding of FDA regulations, ISO standards, EU MDR, and other relevant global regulatory frameworks