Vice President, Global Regulatory Affairs

PROCEPT BioRobotics K.K.; San Jose (CA); On-site; USD 320,000 - 520,000; Full time

Job summary

PROCEPT BioRobotics is seeking a world-class Regulatory Executive to serve as Vice President of Global Regulatory Affairs. This leader will craft and drive a forward-looking regulatory strategy for PROCEPT's surgical robotics portfolio, including oncology indications such as prostate cancer, across multiple global jurisdictions.

The role entails driving submissions, regulatory intelligence, and post-market compliance, with strong emphasis on onboarding and integrating new technologies, and

Qualifications

• VP-level regulatory experience or higher in medical devices.
• Excellent writing skills for regulatory documentation.
• Robust knowledge of clinical, hardware, and software components.
• Experience with AI/ML functionality regulatory submissions, oncology-focused submissions, and PMA-level submissions in surgical robotics.

Responsibilities

• 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 (FDA 510(k), PMA, IDE, EU MDR) that align with PROCEPT BioRobotics' portfolio, including oncology indications.
• Provide expert guidance on strategic, operational, and budgetary planning to optimize regulatory pathways and timelines for new technologies and oncology-related device submissions.
• Work closely with R&D, Quality, Legal, Marketing, Manufacturing, Operations, and Clinical teams to synchronize product development and global regulatory submissions.

Skills

Regulatory leadership

FDA submissions

PMA strategy

Cross-functional collaboration

AI/ML regulatory

Job description

Company Overview

Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.

Understanding PROCEPT's Culture

At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers.

And this doesn't happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept's history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances.

An opportunity at PROCEPT BioRobotics won't just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!

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 emerg