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# VP, Regulatory Affairs with a Medical Device Co. – Irvine, CA


Role Overview for VP, Regulatory Affairs with a Medical Device Co. – Irvine, CA
JRG Partners is proud to exclusively represent a pioneering medical device company based in the vibrant technology hub of Irvine, California. Our client is at the forefront of developing life-changing technologies that significantly improve patient outcomes. They are seeking a visionary and strategic Vice President of Regulatory Affairs to join their executive leadership team. This is a paramount role responsible for architecting and executing the company’s global regulatory strategy, ensuring that innovative products reach markets worldwide in a compliant and efficient manner. The ideal candidate will be a seasoned leader with a profound understanding of the complex international regulatory landscape for medical devices, particularly in the US and EU.
As the VP of Regulatory Affairs, you will be the ultimate authority on regulatory matters within the organization. You will not only lead a talented team of regulatory professionals but also serve as a key strategic advisor to the CEO and the Board of Directors. Your guidance will be critical in navigating the intricate pathways of product development, clinical trials, and commercialization. This position demands a unique blend of technical regulatory expertise, strategic business acumen, and inspirational leadership.
You will be instrumental in fostering a culture of quality and compliance, while simultaneously enabling rapid innovation. This is an exceptional opportunity to make a tangible impact on a growing company and, more importantly, on the lives of patients who depend on these advanced medical technologies. You will be challenged to think creatively, solve complex problems, and drive the regulatory function to become a competitive advantage for the business.
Key Responsibilities of VP, Regulatory Affairs with a Medical Device Co. – Irvine, CA
The Vice President of Regulatory Affairs will assume a wide range of critical responsibilities, steering the company through the complexities of global regulations. Success in this role requires a hands-on yet strategic approach to the following key duties:
Global Regulatory Strategy Development
Design, implement, and oversee comprehensive global regulatory strategies for the company’s entire product portfolio, including new product introductions and lifecycle management of existing products. This includes determining the optimal regulatory pathway for Class II and Class III devices in key markets such as the United States (FDA), European Union (MDR), Canada, Japan, and other international regions.
Regulatory Submissions Leadership
Direct and manage the preparation, submission, and maintenance of all regulatory applications and filings. This encompasses a broad spectrum of submissions, including Premarket Approvals (PMAs), 510(k) Premarket Notifications, De Novo requests, Investigational Device Exemptions (IDEs), and CE Mark technical files/design dossiers under the EU MDR. Ensure all submissions are of the highest quality, scientifically sound, and submitted on schedule.
Health Authority Liaison
Serve as the primary point of contact and build strong, collaborative relationships with regulatory agencies worldwide, including the FDA, Notified Bodies, and other international health authorities. Lead and prepare teams for all formal meetings, negotiations, and communications with these agencies, ensuring professional and effective representation of the company’s interests.
Team Leadership and Mentorship
Lead, inspire, and develop a high-performing global regulatory affairs department. Foster a culture of excellence, accountability, and continuous learning. Provide mentorship and career development opportunities for team members, ensuring the department has the skills and capabilities to meet current and future business needs. Manage departmental budget and resource allocation effectively.
Cross-Functional Collaboration and Counsel
Act as the key regulatory subject matter expert and provide strategic guidance to internal cross-functional teams, including Research & Development, Clinical Affairs, Quality Assurance, Operations, and Marketing. Ensure that regulatory requirements are integrated into the product development process from conception through to commercialization. Review and approve engineering changes, labeling, promotional materials, and clinical trial protocols.
Regulatory Compliance and Quality Systems
Ensure the company’s unwavering compliance with all applicable global regulations and standards. This includes a deep and practical understanding of the FDA’s Quality System Regulation (QSR), medical device reporting (MDR) requirements, corrections and removals, and other post-market obligations. Partner closely with the Head of Quality Assurance to maintain a robust and compliant quality management system (QMS) in accordance with FDA 21 CFR Part 820, ISO 13485, and other relevant standards.
Monitoring Regulatory Intelligence
Proactively monitor, interpret, and analyze the evolving global regulatory landscape. Assess the impact of new regulations, guidance documents, and industry trends on the company’s products and strategies. Effectively communicate this intelligence to senior management and relevant stakeholders, recommending and implementing necessary changes to maintain compliance and competitive advantage.
Post-Market Surveillance and Vigilance
Oversee all post-market regulatory activities, including the management of vigilance reporting, adverse event analysis, health hazard evaluations, and product recalls or field safety corrective actions, if necessary. Ensure that post-market surveillance plans and reports are robust and meet global requirements.
Business Development Support
Provide critical regulatory due diligence support for potential mergers, acquisitions, and strategic partnerships. Evaluate the regulatory status and potential risks associated with target companies, products, or technologies to inform business decisions.
Requirements for the VP, Regulatory Affairs with a Medical Device Co. – Irvine, CA
The successful candidate will be an accomplished regulatory affairs leader with a proven history of success in the medical device industry. The specific qualifications and attributes we are seeking include:
Educational Background
A minimum of a Bachelor’s degree (B.S. or B.A.) in a relevant scientific, engineering, or life sciences discipline is required. An advanced degree (M.S., Ph.D., or J.D.) is strongly preferred and will be a significant differentiator.
Professional Experience
A minimum of 15 years of progressive and relevant experience in regulatory affairs within the medical device sector. This must include at least 7-10 years of experience in a senior leadership capacity, with demonstrated success in managing and developing regulatory teams.
Device-Specific Expertise
Extensive, hands-on experience with high-risk medical devices is mandatory. The candidate must have a proven track record of successfully obtaining approvals for Class II and/or Class III devices, particularly through the FDA’s PMA, 510(k), and De Novo pathways.
Global Regulatory Acumen
Deep and demonstrable expertise in international regulations is essential. This includes mastery of the European Medical Device Regulation (EU MDR 2017/745), as well as experience with regulatory systems in other key markets like Canada, Australia, Japan, and China.
Leadership and Influence
Exceptional leadership skills with the ability to build, mentor, and motivate a world-class regulatory team. The candidate must possess strong executive presence, with the ability to effectively communicate, negotiate, and influence stakeholders at all levels, from engineers to the Board of Directors and external regulatory bodies.
Strategic and Analytical Thinking
Proven ability to think strategically and translate complex regulatory requirements into actionable business plans. Strong analytical and problem-solving skills, with an aptitude for making sound, risk-based decisions in a fast-paced environment.
Communication Skills
Impeccable written and verbal communication skills are non-negotiable. The ability to articulate complex regulatory concepts clearly and concisely to both technical and non-technical audiences is critical for success.
Certifications
Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) is highly desirable.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier talent by offering a highly competitive and comprehensive compensation and benefits package. As a key member of the executive team, you can expect:
Executive Compensation
A highly competitive base salary complemented by a significant annual performance-based bonus and a substantial equity package (stock options or RSUs) that aligns your success with the company’s growth.
Comprehensive Health and Wellness
A full suite of benefits including premium medical, dental, and vision insurance plans for you and your dependents. The package also includes life insurance, short-term and long-term disability coverage.
Retirement Planning
A robust 401(k) retirement savings plan with a generous company match to help you plan for your future.
Work-Life Balance
A generous paid time off (PTO) policy, including vacation, sick leave, and numerous paid holidays, to ensure you have ample time to rest and recharge.
Relocation Support
A comprehensive relocation package is available for exceptional candidates who are not local to the Irvine, CA area.
Professional Growth
A strong commitment to your professional development, with support for attending industry conferences, workshops, and continuing education to stay at the cutting edge of regulatory affairs.
Innovative Culture
The opportunity to work in a dynamic, collaborative, and mission-driven environment where your contributions have a direct impact on advancing healthcare and improving patient lives.
How to Apply
JRG Partners is the exclusive search firm retained for this critical executive leadership position. We are seeking to connect with highly qualified and motivated individuals who meet the stringent requirements outlined above. If you are a strategic regulatory affairs leader ready to take on a new challenge with an industry-leading medical device company, we encourage you to apply.
To be considered for this confidential search, please submit your detailed resume and a compelling cover letter outlining your qualifications and interest in the role. All applications will be treated with the utmost confidentiality. For more information about our expertise in this sector, please visit the JRG Partners’ Life Sciences Executive Search team page. We look forward to reviewing your application.