Role Overview for VP Quality & Regulatory Affairs, Surgical Robotics – Irvine, CA
JRG Partners is proud to represent a pioneering force in the medical technology sector, a company at the forefront of developing next-generation surgical robotics systems. Our client is dedicated to revolutionizing minimally invasive surgery, improving patient outcomes, and empowering surgeons with unparalleled precision and control. Located in the vibrant tech hub of Irvine, California, they are driven by a culture of innovation, collaboration, and an unwavering commitment to quality. We are seeking a visionary and strategic leader to join their executive team as the Vice President of Quality & Regulatory Affairs. This is a career-defining opportunity to shape the quality and regulatory landscape of a rapidly growing organization poised to make a significant impact on global healthcare.
The Vice President of Quality & Regulatory Affairs will be the principal architect and guardian of the company’s global compliance strategy. This executive role is responsible for providing strategic leadership and hands-on direction for all aspects of the Quality Management System (QMS) and global regulatory submissions and compliance. You will be instrumental in guiding the company through critical product development milestones, complex international regulatory approvals, and the scaling of manufacturing operations. As a key member of the senior leadership team, you will collaborate cross-functionally with R&D, Clinical, Operations, and Commercial teams to ensure that quality is embedded in every facet of the product lifecycle, from initial concept to post-market surveillance. Your expertise will be critical in navigating the dynamic regulatory environments in the US, EU, and other key international markets, ensuring timely product launches and sustained market access. This role demands a leader who can balance strategic foresight with meticulous execution, fostering a robust culture of quality and compliance that serves as a competitive advantage and upholds the highest standards of patient safety.
Key Responsibilities of VP Quality & Regulatory Affairs, Surgical Robotics – Irvine, CA
Strategic Leadership
Develop, implement, and champion a global quality and regulatory affairs strategy that aligns with the company’s business objectives, product roadmap, and long-term growth targets. Serve as the primary quality and regulatory voice on the executive leadership team, providing critical insights and guidance on compliance risks and opportunities.
Global Regulatory Strategy & Submissions
Lead the development and execution of comprehensive regulatory strategies for new and modified products in key markets worldwide, including the United States (FDA), Europe (MDR), and Asia-Pacific. Oversee the preparation, submission, and maintenance of all regulatory filings, including 510(k)s, PMAs, De Novo petitions, and technical files/design dossiers.
Regulatory Agency Interaction
Act as the primary liaison with regulatory authorities such as the FDA, Notified Bodies, and other international health agencies. Lead and manage all regulatory inspections, audits, and inquiries, ensuring timely and effective responses.
Quality Management System (QMS) Oversight
Direct and maintain an effective, efficient, and compliant QMS in accordance with global standards, including the FDA’s Quality System Regulation (QSR) under 21 CFR Part 820, ISO 13485, and the EU Medical Device Regulation (MDR). Drive continuous improvement initiatives within the QMS to enhance compliance and operational efficiency.
Design & Development Quality Assurance
Partner closely with the R&D team to integrate quality and compliance requirements into the product development process. Oversee design controls, risk management (ISO 14971), usability engineering, and verification/validation activities to ensure the development of safe, effective, and compliant products.
Operational Quality
Lead all operational quality functions, including supplier quality management, manufacturing quality, process validation, non-conforming material control, and the release of finished products. Ensure robust quality control measures are in place throughout the supply chain and manufacturing process.
Post-Market Surveillance & Vigilance
Establish and manage comprehensive post-market surveillance (PMS) systems, including complaint handling, medical device reporting (MDRs/Vigilance), and trend analysis. Oversee any required field actions or recalls with precision and urgency.
CAPA and Audits
Champion a robust Corrective and Preventive Action (CAPA) program to effectively address systemic issues. Oversee the internal and external audit programs to ensure ongoing compliance and identify areas for improvement.
Team Development & Mentorship
Build, lead, and mentor a world-class team of quality and regulatory affairs professionals. Foster a culture of accountability, collaboration, continuous learning, and excellence within the department and across the organization.
Budget & Resource Management
Develop and manage the departmental budget, ensuring optimal allocation of resources to achieve strategic objectives and maintain compliance.
Requirements for the VP Quality & Regulatory Affairs, Surgical Robotics – Irvine, CA
Educational Background
A minimum of a Bachelor’s degree in Engineering, Life Sciences, or a related technical field is required. An advanced degree (MS, PhD, or MBA) is highly preferred.
Executive Experience
A minimum of 15 years of progressive experience in the medical device industry, with at least 7-10 years in a senior leadership role managing both Quality and Regulatory Affairs functions.
Technical Expertise
Extensive experience with complex, software-driven, electro-mechanical medical devices is essential. Direct experience with surgical robotics, capital equipment, or other active implantable/Class III devices is strongly required.
Regulatory Acumen
Proven track record of successful regulatory submissions and approvals (510(k), PMA, CE Mark) in major global markets. Deep, hands-on knowledge of FDA regulations, ISO 13485, EU MDR, and other international medical device regulations.
Leadership Skills
Demonstrated ability to build, scale, and lead high-performing teams. A strategic thinker with the ability to translate complex regulations and quality principles into actionable business-oriented plans.
Communication & Influence
Exceptional communication, presentation, and interpersonal skills. The ability to effectively influence and negotiate with regulatory agencies, executive peers, and other internal and external stakeholders.
Problem-Solving
Strong analytical and problem-solving skills, with a proven ability to manage complex projects and navigate ambiguity in a fast-paced, start-up or high-growth environment.
Certifications
Regulatory Affairs Certification (RAC) or ASQ certifications (e.g., CQE, CQA) are highly desirable.
Location
The candidate must be able to work on-site at the company’s headquarters in Irvine, CA. Relocation assistance is available for an exceptional candidate.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a comprehensive and competitive compensation and benefits package. They believe in investing in their employees’ well-being and professional growth.
Competitive Salary & Bonus
A highly competitive base salary complemented by a significant annual performance-based bonus plan.
Equity Participation
Meaningful equity/stock options package, allowing you to share in the long-term success of the company.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your dependents with significant employer contributions.
Retirement Savings
A 401(k) retirement plan with a generous company match to help you plan for your future.
Generous Paid Time Off
A flexible and generous paid time off (PTO) policy, including vacation, sick leave, and paid company holidays, to support a healthy work-life balance.
Professional Development
A dedicated budget for continuous learning, including conferences, certifications, and advanced training to support your career growth.
Relocation Assistance
A comprehensive relocation package is available for qualified candidates moving to the Irvine area.
Innovative Culture
An opportunity to work with brilliant minds in a dynamic, collaborative, and mission-driven environment where your contributions have a direct impact on the future of surgery.
How to Apply
This is an exclusive search being conducted by JRG Partners. To be considered for this pivotal leadership role, please submit your resume and a cover letter detailing your relevant experience and qualifications. We encourage you to apply promptly as we are actively reviewing candidates. JRG Partners is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all candidates.
For more information about our expertise in this sector or to explore other opportunities, please visit our Surgical Robotics Executive Recruiters practice area page.
