Vice President, Global Regulatory Affairs

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

The Opportunity That Awaits You

As PROCEPT BioRobotics’ continues to evolve and expand its global footprint, we seek a world-class regulatory executive to serve as Vice President (VP) of Global Regulatory Affairs (RA). This role will report into the SVP of Global RAQA. This leader will architect and execute a forward-looking, comprehensive regulatory strategy supporting PROCEPT BioRobotics’ complex surgical robotics portfolio—including oncology applications such as prostate cancer—and other emerging technologies. The successful candidate has a proven track record guiding diverse, cross-functional teams to regulatory success in multiple global jurisdictions, while fostering a culture of compliance, agility, and innovation.

This role will assume full responsibility for both strategic and operational RA initiatives—driving regulatory submissions and approvals, cutting edge regulatory intelligence, global market entry, and post-market compliance. The ideal candidate has at least two years of prior VP-level experience, excels at on-boarding different or emerging technologies, and possesses excellent writing skills and robust knowledge of clinical, hardware, and software components. Experience with complex product categories, including software releases including artificial intelligence/machine language (AI/ML) functions, oncology-focused submissions (e.g., prostate cancer) and PMA-level submissions in surgical robotics, is highly desired.

What Your Day-To-Day Will Involve

Regulatory Leadership & Strategy

• Develop, refine, and maintain an agile global regulatory infrastructure and regulatory intelligence to address evolving market and compliance demands
• Oversee robust US and global regulatory strategies (e.g., FDA 510(k), PMA, IDE, EU MDR) that align with PROCEPT BioRobotics’ complex surgical robotics and associated accessories, including oncology-specific indications such as prostate cancer. Lead software-based submissions that support AI/ML related functionality
• Provide expert guidance on strategic, operational, and budgetary planning to optimize regulatory pathways and timelines for new technologies and oncology-related device submissions

Cross-Functional Collaboration

• Work closely with R&D, Quality, Legal, Marketing, Manufacturing, Operations, and Clinical teams to synchronize product development and global regulatory submissions, ensuring alignment with corporate objectives
• Engage with leadership and board members on evolving regulatory requirements, effectively articulating opportunities, risks, and strategies
• Guide PROCEPT BioRobotics’ in on-boarding and integrating new or emerging technologies, ensuring compliant product development cycles and swift market entry. This includes but is not limited to supporting the implementation of global distribution agreements for adjacent technologies that complement PROCEPT BioRobotics’ product portfolio

Team Development & Management

• Be a leader that embodies the values of PROCEPT BioRobotics
• Build, mentor, and lead a high-performing global RA team; cultivate a pipeline of future leaders through professional development and succession planning
• Establish clear performance metrics and a structured framework for training and ongoing skill enhancement.
• Ensure resource allocation (budgeting, staffing, and talent management) meets corporate growth objectives.

Global Compliance & Submissions

• Serve as the primary liaison with FDA, notified bodies, and other regulatory authorities; nurture constructive, transparent, and credible agency relationships
• Drive all aspects of domestic and international product registrations, submissions, and renewals with emphasis
• Support post-market surveillance, vigilance, and MDR reporting processes

Regulatory Systems & Policies

• Enhance and maintain the regulatory management system, aligning it with PROCEPT BioRobotics’ dynamic business goals and quality management system (QMS)
• Develop, implement, and update policies and procedures to ensure adherence to local, national, and international regulations and certification standards
• Establish best practices and key performance metrics for optimizing submission cycle times and improving approval outcomes

Stakeholder Communication & Support

• Review and advise marketing on labeling, product claims, promotional materials, press releases, training documents, and complaints to ensure regulatory and legal compliance
• Coordinate strategic planning and regulatory input for clinical trials including supporting oncology-specific indications (e.g., prostate cancer), ensuring data supports pivotal submissions
• Provide authoritative guidance on risk management, data integrity, and documentation standards for all regulatory filings
• Build a strong regulatory intelligence program to monitor, interpret, and respond proactively to emerging global regulations, standards, and industry trends, particularly in software driven, AI/ML related high-tech medical robotics and oncology
• Lead or participate in internal committees, task forces, and special projects, championing initiatives to streamline regulatory processes and deliver corporate agility

Corporate Compliance

• Ensure full compliance with PROCEPT BioRobotics’ Quality Policy, EHS Policy, and any relevant local, state, or federal regulations
• Maintain the highest standards of ethics, integrity, and accountability throughout all regulatory processes and communications.

Supervisory 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

The Qualifications We Need You To Possess

• 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); experience in global markets (EU, Japan, China)
• 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
• Solid background in complex device ecosystems, including hardware/software integration; experience in robotic-assisted surgical devices strongly desired

The Qualifications We Would Like You To Possess

• Experience in successfully using pre-determined change control plan (PCCP) in submissions is desirable
• Exceptional team-building abilities and a passion for developing talent across geographically distributed teams
• Skilled at influencing internal and external stakeholders, including top executives, board members, and regulatory authorities
• Adept at balancing risk management with the need for timely and innovative product development.