Global Regulatory Chief for Surgical Robotics & AI/ML

PROCEPT BioRobotics; San Francisco (CA); On-site; USD 260,000 - 360,000; Full time

Job summary

PROCEPT BioRobotics seeks a world-class Vice President of Global Regulatory Affairs to architect a forward-looking regulatory strategy for a complex surgical robotics portfolio, including oncology indications. The role involves leading global submissions, regulatory intelligence, and post-market compliance across multiple jurisdictions, with emphasis on AI/ML functionality and software-driven components.

The ideal candidate has 20+ years in regulatory affairs for medical devices, strong

Qualifications

• Minimum 20+ years of progressive regulatory affairs experience in medical devices.
• Experience in global markets (EU, Japan, China) and IDEs/PMAs is highly desirable.
• Excellent writing and communication skills with successful regulatory submissions.

Responsibilities

• Develop, refine, and maintain a global regulatory infrastructure and intelligence.
• Oversee US and global regulatory strategies (FDA 510(k), PMA, IDE, EU MDR).
• Lead strategic, operational, and budget planning for regulatory pathways and timelines.

Skills

Regulatory leadership

FDA/regulatory submissions

Global regulatory strategy

Education

BS/BA in STEM

Advanced degree preferred

Job description

PROCEPT BioRobotics seeks a world-class Vice President of Global Regulatory Affairs to architect a forward-looking regulatory strategy for a complex surgical robotics portfolio, including oncology indications. The role involves leading global submissions, regulatory intelligence, and post-market compliance across multiple jurisdictions, with emphasis on AI/ML functionality and software-driven components.

The ideal candidate has 20+ years in regulatory affairs for medical devices, strong