Role Overview for Chief Regulatory Officer – San Diego, CA
JRG Partners is proud to announce an exclusive executive search for a visionary and strategic Chief Regulatory Officer (CRO) on behalf of our client, a pioneering medical device company headquartered in the vibrant life sciences hub of San Diego, CA. This is a rare opportunity to join the executive leadership team of a rapidly growing organization dedicated to revolutionizing patient care through groundbreaking technology. As the CRO, you will be the principal architect of the company’s global regulatory strategy, providing the critical guidance necessary to navigate the complex international landscape of medical device regulations.
Reporting directly to the Chief Executive Officer, you will be a key member of the C-suite, contributing to the company’s strategic direction and long-term success. Your leadership will be instrumental in ensuring that our client’s innovative products reach patients worldwide in a compliant and efficient manner. You will be responsible for building and mentoring a world-class regulatory affairs team, fostering a culture of excellence, integrity, and collaboration. This role demands a leader who can balance strategic foresight with hands-on execution, a professional who thrives in a dynamic, fast-paced environment and is passionate about bringing life-changing medical technologies to market.
The ideal candidate will not only be a master of regulatory science but also a strategic business partner who can translate complex regulatory requirements into actionable business insights and competitive advantages. You will serve as the company’s primary voice to global health authorities, building relationships based on trust and transparency. If you are a seasoned regulatory leader with a proven track record in the medical device sector and a desire to make a profound impact, we invite you to explore this career-defining opportunity.
Key Responsibilities of Chief Regulatory Officer – San Diego, CA
The Chief Regulatory Officer will have a broad and impactful scope of responsibilities, essential for the company’s growth and market leadership. Your duties will include:
Global Regulatory Strategy Development
Formulate, implement, and lead comprehensive global regulatory strategies for the entire product portfolio, from early-stage development through post-market surveillance. Ensure alignment of regulatory strategy with corporate objectives across key markets, including the US, EU, Canada, Japan, and other emerging regions.
Regulatory Submissions and Approvals
Direct and oversee the preparation, submission, and lifecycle management of all regulatory filings. This includes Investigational Device Exemptions (IDEs), Premarket Approvals (PMAs), 510(k) Premarket Notifications, De Novo requests, and international submissions such as CE Mark Technical Files under EU MDR.
Health Authority Engagement
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. Proactively lead all communications, meetings, and negotiations to ensure positive and productive outcomes.
Team Leadership and Development
Recruit, train, mentor, and lead a high-performing regulatory affairs department. Establish clear goals, provide ongoing coaching, and foster a collaborative environment that promotes professional growth, accountability, and regulatory excellence.
Cross-Functional Partnership
Act as a strategic partner to internal teams, including R&D, Clinical Affairs, Quality Assurance, Manufacturing, and Commercial. Provide expert regulatory guidance throughout the product lifecycle to ensure that regulatory requirements are embedded in product design, development, and validation processes.
Regulatory Intelligence and Policy
Continuously monitor, analyze, and interpret the evolving global regulatory environment. Proactively assess the impact of new regulations, guidance documents, and industry standards on the company’s products and strategies, and effectively communicate these insights to the executive team.
Compliance and Quality System Oversight
Collaborate closely with the Head of Quality to ensure the company’s Quality Management System (QMS) is robust and compliant with all applicable regulations, including FDA 21 CFR 820 (QSR) and ISO 13485. Play a key role in managing regulatory inspections and audits.
Post-Market Compliance
Oversee all post-market regulatory activities, including the management of adverse event reporting, vigilance systems, medical device reporting (MDRs), product recalls, and field safety corrective actions, ensuring timely and compliant execution.
Budget and Resource Management
Develop and manage the annual budget for the Regulatory Affairs department, ensuring the strategic allocation of financial and human resources to achieve departmental and corporate goals.
Requirements for the Chief Regulatory Officer – San Diego, CA
The successful candidate will be a proven leader with deep expertise in the medical device industry. The qualifications for this critical role are:
Educational Background
An advanced degree (M.S., Ph.D., M.D., or J.D.) in a relevant scientific, engineering, or legal discipline is strongly preferred. A Bachelor’s degree in a related field is required.
Professional Experience
A minimum of 15 years of progressive experience in regulatory affairs within the medical device industry, with at least 7-10 years in a senior leadership capacity (e.g., Vice President, Senior Director) managing teams and global strategies.
Technical Regulatory Expertise
Demonstrated, in-depth knowledge and a successful track record with various types of regulatory submissions for Class II and Class III medical devices. Extensive experience with 510(k)s, PMAs, IDEs, and CE Marking under the new EU MDR is essential.
Global Regulatory Knowledge
Proven experience in securing product approvals and managing regulatory compliance in multiple international markets. Must possess a comprehensive understanding of global regulatory frameworks and be adept at navigating diverse health authority expectations. A deep familiarity with the FDA regulations for medical devices is a foundational requirement.
Strategic Leadership
Exceptional strategic thinking and problem-solving skills. The ability to anticipate regulatory trends, identify potential risks, and develop innovative solutions to complex challenges is critical. Must have experience presenting to and advising a Board of Directors.
Communication and Influence
Superior written and verbal communication skills. Must be able to articulate complex regulatory concepts clearly and persuasively to a wide range of stakeholders, from technical teams to executive leadership and regulatory agencies.
Interpersonal Acumen
A collaborative leader with a high degree of emotional intelligence. Proven ability to build and maintain strong working relationships with internal and external partners, fostering an environment of mutual respect and trust.
Location
The candidate must be based in or willing to relocate to the San Diego, CA metropolitan area.
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. This includes:
Executive Compensation
A competitive base salary complemented by a significant annual performance-based bonus and a meaningful long-term equity incentive package.
Comprehensive Health and Wellness
Top-tier medical, dental, and vision insurance plans for you and your dependents.
Retirement Savings
A robust 401(k) plan with a generous company matching contribution.
Work-Life Balance
A generous paid time off (PTO) policy, including vacation, sick leave, and paid company holidays.
Relocation Support
A comprehensive relocation assistance package is available for qualified candidates.
Professional Growth
Ample opportunities for professional development, including support for attending industry conferences, workshops, and continuing education.
Impactful Culture
The opportunity to work within a mission-driven, innovative, and collaborative culture where your contributions directly impact patient lives and the success of the company.
How to Apply
JRG Partners is the exclusive retained search firm for this Chief Regulatory Officer position. To be considered for this confidential opportunity, please submit your resume and a cover letter detailing your qualifications and interest in the role. All inquiries and applications will be handled with the utmost discretion.
We encourage you to learn more about our specialized recruitment services by visiting JRG Partners’ Medical Device & Diagnostics executive search practice. We are dedicated to connecting exceptional leaders with transformative opportunities.
Our client is an Equal Opportunity Employer and values diversity at their company. They do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
