Role Overview for VP, Regulatory Affairs, Devices with a MedTech Company – Irvine, CA
JRG Partners is proud to partner with a pioneering medical technology company in their search for a visionary and strategic Vice President of Regulatory Affairs. Based in the vibrant MedTech hub of Irvine, California, this executive leadership role is a career-defining opportunity to shape the global regulatory landscape for a portfolio of life-changing medical devices. Our client is at the forefront of innovation, developing next-generation technologies that address critical unmet medical needs. As a key member of the executive team, you will be the central pillar of their global commercialization strategy, ensuring that these groundbreaking products reach patients and clinicians worldwide in a compliant and efficient manner.
This is not merely a compliance function; it is a strategic business partnership. The VP of Regulatory Affairs will provide critical insights and guidance that influence product design, clinical trial strategy, and international market expansion. You will be responsible for building and mentoring a world-class regulatory team, fostering a culture of excellence, proactive problem-solving, and unimpeachable integrity. Your leadership will directly impact the company’s growth trajectory, market position, and, most importantly, its ability to improve patient outcomes. We are seeking a leader who can navigate the complexities of global regulations with sophistication, build strong relationships with health authorities, and champion a regulatory vision that enables, rather than hinders, innovation.
You will be entrusted with the ultimate responsibility for the company’s relationship with regulatory bodies across the globe, including the FDA, EU Notified Bodies, and other international health authorities. Your expertise will be paramount in steering the company through the evolving challenges of the medical device industry, from new submission pathways to post-market surveillance requirements. If you are a seasoned regulatory affairs professional with a passion for medical technology and a proven track record of bringing complex devices to market, we invite you to explore this exceptional opportunity to make a lasting impact.
Key Responsibilities of VP, Regulatory Affairs, Devices with a MedTech Company – Irvine, CA
Global Regulatory Strategy
Develop, articulate, and execute comprehensive global regulatory strategies for the entire product lifecycle, from concept to commercialization and post-market. Ensure strategies are aligned with business objectives, timelines, and budget.
Executive Leadership & Counsel
Serve as the primary regulatory authority on the executive leadership team. Provide expert counsel on regulatory risks, opportunities, and the potential impact of new or changing regulations on the business.
Team Development & Mentorship
Lead, manage, and scale a high-performing global regulatory affairs department. Recruit top talent, provide ongoing mentorship and professional development, and foster a collaborative and results-oriented team culture.
Regulatory Submissions
Oversee the planning, preparation, and submission of all regulatory filings, including but not limited to Premarket Approvals (PMAs), 510(k)s, De Novo requests, Investigational Device Exemptions (IDEs), and CE Mark applications under the EU MDR. Ensure all submissions are of the highest quality and are submitted on schedule.
Health Authority Engagement
Act as the principal point of contact with the FDA, Notified Bodies, and other international regulatory agencies. Cultivate and maintain strong, positive relationships with regulators, and lead all negotiations and communications related to product approvals, compliance issues, and inspections.
Compliance & Quality Systems Integration
Ensure robust compliance with all applicable regulations and standards, including QSR (21 CFR 820), ISO 13485, and EU MDR. Partner closely with the VP of Quality Assurance to ensure regulatory requirements are seamlessly integrated into the company’s Quality Management System (QMS).
Post-Market Surveillance
Oversee all post-market activities, including vigilance, adverse event reporting, recalls, and field safety corrective actions. Develop and implement strategies for managing post-market data collection and reporting requirements.
Cross-Functional Collaboration
Serve as a key strategic partner to R&D, Clinical, Operations, and Commercial teams. Provide critical regulatory input during product development, design controls, risk management, and labeling development to ensure regulatory requirements are met from the earliest stages.
Regulatory Intelligence
Continuously monitor the global regulatory landscape for changes in laws, regulations, and guidance. Analyze the potential impact on the company’s products and strategies, and proactively develop plans to adapt and comply.
Budget Management
Develop and manage the annual budget for the Regulatory Affairs department, ensuring efficient allocation of resources to meet strategic objectives.
Requirements for the VP, Regulatory Affairs, Devices with a MedTech Company – Irvine, CA
Educational Background
A minimum of a Bachelor’s degree in a scientific, engineering, or related field is required. An advanced degree (MS, PhD, MD, or JD) is highly preferred.
Professional Experience
A minimum of 15 years of progressive experience within the medical device regulatory affairs field, with at least 7-10 years in a significant leadership role managing teams and strategy.
Device Expertise
Extensive, hands-on experience with high-risk devices is mandatory. A proven track record of successful PMA submissions for Class III devices is a critical requirement. Deep experience with Class II 510(k) pathways is also essential.
Regulatory Acumen
Expert-level knowledge of U.S. FDA regulations for medical devices (e.g., 21 CFR Parts 803, 806, 807, 812, 820). Comprehensive understanding and practical application experience with the European Medical Device Regulation (EU MDR 2017/745).
Global Experience
Demonstrated success in securing product approvals and managing regulatory compliance in key international markets beyond the US and EU (e.g., Canada, Japan, China, Australia).
Leadership & Influence
Exceptional leadership skills with the ability to inspire and motivate a team. Proven ability to operate at both strategic and tactical levels. Must possess executive presence and the ability to effectively communicate complex regulatory concepts to diverse audiences, including boards of directors.
Communication Skills
Impeccable written and verbal communication skills. The ability to negotiate effectively and build consensus with both internal and external stakeholders is paramount.
Strategic Thinking
Strong business acumen and the ability to translate regulatory requirements into actionable business strategies. Must be a strategic thinker who can anticipate future trends and challenges.
Location
The position is based in Irvine, CA, and requires a significant in-office presence to effectively lead the team and collaborate with executive peers.
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 executive, you can expect:
Executive Compensation
A highly competitive base salary commensurate with experience, coupled with a significant annual performance-based bonus.
Equity Participation
A substantial long-term incentive package, including stock options or restricted stock units (RSUs), to ensure you share in the company’s success.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your eligible dependents, with low employee contributions.
Retirement Savings
A robust 401(k) plan with a generous company matching contribution 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.
Family Support
Comprehensive parental leave policies to support growing families.
Professional Growth
A dedicated budget for professional development, including attendance at major industry conferences, executive coaching, and continuing education.
Relocation Assistance
A comprehensive relocation package is available for exceptional candidates moving to the Irvine area.
How to Apply
This is an exclusive search being conducted by JRG Partners. To be considered for this pivotal leadership role, we invite qualified candidates to submit a confidential resume and a cover letter detailing their relevant experience and strategic accomplishments. Please direct all inquiries and applications through our dedicated portal. We are committed to a thorough and confidential review process. To learn more about our specialized expertise in this sector, please visit our Medical Device & Diagnostics Recruiting Practice page.
Our client is an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. We celebrate diversity and are committed to creating an inclusive environment for all employees.
