Role Overview for EVP, Global Regulatory Affairs with a Medical Device Co. – Irvine, CA
JRG Partners is proud to partner with a pioneering, globally recognized medical device company in their search for an Executive Vice President (EVP), Global Regulatory Affairs. Based in the vibrant life sciences hub of Irvine, California, this is a career-defining opportunity for a visionary leader to shape the regulatory landscape of an organization committed to improving patient outcomes through groundbreaking technology.
This executive will serve as a critical member of the senior leadership team, reporting directly to the Chief Executive Officer, and will be the principal architect of the company’s global regulatory strategy. The ideal candidate is a strategic thinker with an impeccable track record of successful product approvals, a deep understanding of the evolving global regulatory environment, and the executive presence to inspire a world-class team. You will be responsible for ensuring that the company’s innovative products not only meet but exceed the stringent requirements of health authorities worldwide, thereby enabling market access and driving sustainable business growth.
This role demands a unique blend of scientific acumen, business savvy, and inspirational leadership. You will be the primary liaison with regulatory bodies such as the FDA, EU Notified Bodies, and other international agencies, building relationships founded on trust and transparency. Your guidance will be instrumental in navigating complex regulatory pathways for a diverse portfolio of products, including next-generation implantables, advanced diagnostic tools, and software as a medical device (SaMD). This is more than a compliance function; it is a strategic business partnership that directly impacts the company’s ability to bring life-changing innovations to patients and clinicians around the globe.
Key Responsibilities of EVP, Global Regulatory Affairs with a Medical Device Co. – Irvine, CA
The EVP, Global Regulatory Affairs will have a broad and impactful scope of responsibilities, encompassing strategic leadership, operational excellence, and team development. Success in this role will be measured by the ability to create and execute a forward-thinking regulatory strategy that aligns with corporate objectives and accelerates product-to-market timelines.
Strategic Regulatory Leadership
Develop, articulate, and implement a comprehensive global regulatory vision and strategy that supports the company’s long-term growth and innovation pipeline. Serve as the key regulatory advisor to the CEO, Board of Directors, and the executive leadership team on all regulatory matters, potential risks, and strategic opportunities.
Global Product Submissions and Approvals
Provide executive oversight for the planning, preparation, and submission of all regulatory applications worldwide. This includes Premarket Approvals (PMAs), 510(k)s, De Novo requests, Investigational Device Exemptions (IDEs), CE Markings under EU MDR/IVDR, and other international dossiers. Ensure submissions are of the highest quality to facilitate timely and successful reviews.
Health Authority Engagement
Act as the primary senior-level contact with global health authorities. Lead and cultivate strong, collaborative relationships with the FDA, Notified Bodies, and other international regulatory agencies. Represent the company during critical negotiations, meetings, and inspections.
Regulatory Intelligence and Policy
Proactively monitor, interpret, and analyze the evolving global regulatory landscape. Assess the impact of new regulations, guidance documents, and industry standards on the company’s portfolio and business strategy. Influence regulatory policy through engagement with industry trade associations and government bodies.
Team Leadership and Development
Lead, mentor, and develop a high-performing, global regulatory affairs organization. Foster a culture of excellence, collaboration, accountability, and continuous improvement. Attract and retain top-tier regulatory talent and provide clear pathways for professional growth. Manage departmental budgets, resource allocation, and operational efficiency.
Cross-Functional Collaboration
Partner seamlessly with R&D, Clinical Affairs, Quality Assurance, Operations, and Commercial teams to integrate regulatory strategy throughout the entire product lifecycle, from concept to post-market surveillance. Provide critical regulatory input for product development, clinical trial design, and labeling.
Compliance and Post-Market Oversight
Ensure robust systems are in place for maintaining regulatory compliance on a global scale. Oversee post-market surveillance activities, including the management of adverse event reporting, product recalls, and field safety corrective actions, ensuring all activities are conducted ethically and in full compliance with applicable regulations.
Requirements for the EVP, Global Regulatory Affairs with a Medical Device Co. – Irvine, CA
This senior executive role requires a seasoned leader with extensive experience and a proven history of success within the medical device industry. The qualifications below represent the ideal background for a candidate to thrive in this challenging and rewarding position.
Educational Background
An advanced degree (M.S., Ph.D., M.D., or J.D.) in a scientific, engineering, or related field is strongly preferred. A Bachelor’s degree in a relevant discipline is required. Regulatory Affairs Certification (RAC) is highly desirable.
Executive Experience
A minimum of 15-20 years of progressive experience in medical device regulatory affairs, with at least 10 years in a significant leadership role managing a global team. Demonstrable experience operating at a Vice President or senior executive level is essential.
Technical Regulatory Expertise
Deep and comprehensive knowledge of U.S. Food and Drug Administration (FDA) regulations for medical devices, particularly for Class II and Class III devices. Extensive, hands-on experience with PMA, 510(k), and IDE submissions is mandatory. Proven expertise with international regulations, including EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), and experience securing approvals in key markets such as Japan, China, Canada, and Australia.
Strategic Acumen
Proven ability to think strategically and translate complex regulatory requirements into actionable business strategy. Experience providing regulatory guidance for due diligence in M&A activities is a plus.
Leadership and Influence
Exceptional leadership skills with a track record of building, motivating, and retaining high-performing teams. Must possess outstanding executive presence, with the ability to communicate complex information clearly and persuasively to a wide range of audiences, from engineers to the Board of Directors.
Communication and Interpersonal Skills
Impeccable written and verbal communication skills. A natural collaborator with the ability to build strong, trust-based relationships with internal and external stakeholders, including senior executives and regulatory agency officials.
Problem-Solving and Judgment
Superior analytical and problem-solving skills. The ability to make sound, risk-based decisions in a fast-paced, high-pressure environment. A high level of integrity, ethics, and sound judgment is non-negotiable.
Benefits & Perks Offered
Our client is committed to attracting and retaining top executive talent by offering a highly competitive and comprehensive compensation and benefits package. This includes:
Executive Compensation
A highly competitive base salary commensurate with experience and market standards.
Incentive Programs
A significant annual performance-based bonus and a generous long-term incentive plan (e.g., stock options, RSUs) designed to reward strategic contributions and long-term value creation.
Comprehensive Health & Wellness
Premier medical, dental, and vision insurance plans for you and your eligible dependents. A robust wellness program, including an employee assistance program (EAP) and fitness incentives.
Retirement Savings
A 401(k) retirement 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 company holidays.
Professional Development
A dedicated budget for continuous learning, including executive coaching, conference attendance, and professional memberships.
Relocation Assistance
A comprehensive relocation package is available for the ideal candidate relocating to the Irvine, CA area.
How to Apply
This is an exclusive, retained search conducted by JRG Partners. If you are a transformative regulatory leader ready to make a significant impact at a world-class medical device company, we encourage you to apply. All applications will be treated with the strictest confidence. To be considered for this pivotal role, please submit your resume and a cover letter outlining your qualifications and strategic accomplishments. For more information on our expertise in this sector, please visit our Life Sciences and Healthcare practice area. We look forward to connecting with you to discuss this exceptional opportunity in detail. JRG Partners and our client are Equal Opportunity Employers.
