VP, Global Regulatory Affairs - Surgical Robotics

PROCEPT BioRobotics; San Jose (CA); On-site; USD 267,000 - 314,000; Full time

Job summary

PROCEPT BioRobotics in California seeks a world-class Vice President of Global Regulatory Affairs to lead regulatory strategy for our surgical robotics portfolio, including AI/ML software integrations and oncology indications. This role will architect and execute a forward-looking regulatory plan across multiple global jurisdictions.

You will drive regulatory submissions, guide strategic and operational activities, and partner with R&D, Quality, Legal, Marketing, Manufacturing, and Clinical

Qualifications

• BS/BA in a relevant scientific, engineering, or medical discipline; advanced degree strongly preferred.
• Minimum 20+ years of regulatory affairs experience in the medical device industry, with at least 2 years in a VP or equivalent senior leadership role.
• Proven track record with global submissions (EU, Japan, China) and AI/ML software/hardware submissions.
• Excellent writing and communication skills demonstrated in regulatory submissions and briefing documents.

Responsibilities

• Develop and maintain a global regulatory infrastructure and regulatory intelligence to address evolving market demands.
• Oversee US and global regulatory strategies (FDA, 510(k), PMA, IDE, EU MDR) for surgical robotics and AI/ML features.
• Provide guidance on budgeting, timelines, and strategic planning for new technologies and oncology submissions.
• Collaborate with R&D, Quality, Legal, Marketing, Manufacturing, Operations, and Clinical teams to align product development and submissions.
• Lead and mentor a global Regulatory Affairs team; establish performance metrics and training programs.
• Coordinate regulatory input for clinical trials and oncology-related submissions, ensuring data supports pivotal filings.
• Maintain relationships with FDA and other authorities; ensure compliance and timely renewals.

Skills

Regulatory leadership

Cross-functional collaboration

Strategic planning

Communication skills

Regulatory submissions

Education

BS/BA in science/engineering/medical

MS/PhD strongly preferred

Job description

PROCEPT BioRobotics in California seeks a world-class Vice President of Global Regulatory Affairs to lead regulatory strategy for our surgical robotics portfolio, including AI/ML software integrations and oncology indications. This role will architect and execute a forward-looking regulatory plan across multiple global jurisdictions.

You will drive regulatory submissions, guide strategic and operational activities, and partner with R&D, Quality, Legal, Marketing, Manufacturing, and Clinical