Role Overview for EVP, Global Regulatory Affairs with a MedTech Company – Irvine, CA
JRG Partners is proud to partner with a pioneering, high-growth medical technology company in their search for an exceptional Executive Vice President (EVP), Global Regulatory Affairs. Based in the MedTech hub of Irvine, California, this is a career-defining opportunity to join a dynamic executive leadership team and shape the future of healthcare innovation. Our client is at the forefront of developing life-changing medical devices, and they are seeking a visionary leader to architect and execute a world-class global regulatory strategy that will accelerate patient access to their groundbreaking products.
As the EVP, Global Regulatory Affairs, you will be the company’s chief regulatory strategist, responsible for navigating the complex and ever-evolving landscape of international medical device regulations. You will provide the critical leadership necessary to guide products from conception through to commercialization and post-market surveillance across key global markets. This role demands a unique blend of deep regulatory expertise, strategic foresight, and inspirational leadership. You will be instrumental in building and mentoring a global team of regulatory professionals, fostering a culture of compliance, excellence, and collaboration. Reporting directly to the CEO, you will serve as a key advisor to the board and executive team, ensuring that regulatory considerations are seamlessly integrated into the company’s core business strategy. This is more than a job; it’s a chance to make a tangible impact on global health outcomes by bringing essential medical technologies to patients and clinicians worldwide.
Key Responsibilities of EVP, Global Regulatory Affairs with a MedTech Company – Irvine, CA
Strategic Leadership
Develop, articulate, and execute a comprehensive global regulatory strategy that aligns with the company’s commercial goals and product pipeline. Provide strategic counsel to the executive leadership team on regulatory risks, opportunities, and the global regulatory environment.
Global Submissions & Approvals
Direct and oversee the preparation, submission, and maintenance of all regulatory applications and registrations. This includes but is not limited to Premarket Approvals (PMAs), 510(k)s, Investigational Device Exemptions (IDEs), CE Markings under EU MDR, and other international dossiers for markets in Asia-Pacific, Latin America, and beyond.
Team Development & Management
Lead, mentor, and scale a high-performing global regulatory affairs organization. Foster a culture of accountability, continuous improvement, and professional growth. Attract and retain top-tier regulatory talent.
Health Authority Engagement
Serve as the primary senior-level liaison with global regulatory agencies, including the FDA, Notified Bodies, and other international health authorities. Cultivate strong, professional relationships and lead negotiations on complex regulatory matters.
Compliance & Quality Systems
Partner closely with the Head of Quality to ensure robust quality management systems and ongoing compliance with all applicable regulations, including FDA’s Quality System Regulation (QSR), ISO 13485, EU MDR/IVDR, and other country-specific requirements. Oversee regulatory audits and inspections.
Product Lifecycle Management
Provide expert regulatory guidance to cross-functional teams (R&D, Clinical, Operations, Marketing) throughout the entire product lifecycle, from initial concept and design control to post-market surveillance and labeling changes.
Regulatory Intelligence
Proactively monitor, analyze, and interpret new and evolving regulatory requirements, guidance documents, and industry standards. Translate regulatory intelligence into actionable strategies and communicate potential impacts to the business.
Due Diligence & Business Development
Act as the regulatory subject matter expert for potential M&A, licensing, and partnership activities, conducting thorough due diligence and risk assessments.
Budget & Resource Planning
Develop and manage the annual budget for the Global Regulatory Affairs department, ensuring optimal allocation of resources to meet strategic objectives.
Requirements for the EVP, Global Regulatory Affairs with a MedTech Company – Irvine, CA
Educational Background
An advanced degree (M.S., Ph.D., M.D., or J.D.) in a scientific, engineering, medical, or legal discipline is strongly preferred. A Bachelor’s degree in a relevant field is required.
Executive Experience
A minimum of 15-20 years of progressive experience in regulatory affairs within the medical device industry, with at least 10 years in a senior leadership capacity (VP level or higher) managing a global team.
Global Regulatory Mastery
Demonstrated track record of successfully securing approvals for complex medical devices in major global markets. Possess a deep and nuanced understanding of the U.S. Food and Drug Administration’s (FDA) requirements for medical devices, the European Medical Device Regulation (MDR), and regulatory frameworks in other key regions like Japan, China, and Canada.
Device Expertise
Extensive experience with a range of medical devices, including complex Class II and Class III devices. Experience with active implantables, diagnostic imaging, digital health, or Software as a Medical Device (SaMD) is highly advantageous.
Leadership & Influence
Proven ability to build, lead, and inspire a global, multi-disciplinary team. Exceptional executive presence, with the ability to communicate complex regulatory concepts clearly and persuasively to diverse audiences, including boards of directors, investors, and regulatory bodies.
Strategic & Business Acumen
A strategic thinker who can seamlessly integrate regulatory strategy with overall business objectives. Experience providing regulatory input that has directly contributed to commercial success and company growth.
Collaboration & Communication
Excellent interpersonal and communication skills, with a demonstrated ability to build strong, collaborative relationships with both internal and external stakeholders.
Location
Must be able to work from the company’s headquarters in Irvine, CA. A comprehensive relocation package is available for the right candidate.
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, significant annual performance-based bonus, and a meaningful long-term incentive package (equity/stock options).
Comprehensive Health & Wellness
Premium medical, dental, and vision insurance for you and your dependents, along with robust mental health support, and wellness programs.
Retirement Savings
A 401(k) plan with a generous company match to help you plan for your future.
Work-Life Balance
Generous paid time off (PTO), company holidays, and supportive parental leave policies.
Professional Growth
Opportunities for continued professional development, including executive coaching and attendance at key industry conferences.
Relocation Support
A comprehensive relocation package for candidates moving to the Irvine, CA area.
Impactful Culture
The opportunity to work in a collaborative, mission-driven environment where your contributions directly impact patient lives and the future of medicine.
How to Apply
This is an exclusive search being conducted by JRG Partners. If you are a transformative regulatory leader with the experience and passion to drive a leading MedTech company to new heights, we encourage you to apply. To be considered for this confidential opportunity, please submit your resume and a cover letter detailing your qualifications.
JRG Partners specializes in placing elite executives within the healthcare and technology sectors. To learn more about our expertise in this area, please visit JRG Partners’ Life Sciences executive search practice. We look forward to connecting with you.
Our client is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
