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Role Overview for Head of Regulatory Affairs with a Medical Device Co. – San Diego, CA
JRG Partners is proud to announce an exclusive search for a visionary and strategic Head of Regulatory Affairs on behalf of our client, a pioneering medical device company based in the vibrant life sciences hub of San Diego, CA. This is a career-defining opportunity to join a dynamic executive team and shape the regulatory landscape for a portfolio of innovative, life-changing medical technologies. Our client is at the forefront of developing next-generation devices that address critical unmet medical needs, and they are seeking a leader who can navigate the complex global regulatory environment with expertise, foresight, and a collaborative spirit.
As the Head of Regulatory Affairs, you will be the central pillar of the company’s global compliance and market access strategy. This is not merely a functional role; it is a strategic leadership position that will have a direct and profound impact on the company’s growth trajectory and its ability to deliver groundbreaking products to patients and clinicians worldwide. You will be responsible for developing and executing comprehensive regulatory strategies from concept through to post-market surveillance. You will serve as the primary liaison with regulatory agencies such as the FDA, Notified Bodies, and other international health authorities, building relationships based on trust, transparency, and scientific rigor.
The ideal candidate will be a seasoned leader with a deep understanding of the intricacies of medical device regulations, including but not limited to FDA 21 CFR 820, EU MDR, and ISO 13485. You will be a strategic thinker, capable of translating complex regulatory requirements into actionable business plans and providing critical guidance to cross-functional teams, including R&D, Clinical, Quality, and Marketing. Your leadership will be instrumental in fostering a culture of compliance and quality throughout the organization, ensuring that regulatory excellence is a competitive advantage. This role requires a hands-on approach, a passion for innovation, and the executive presence to influence key stakeholders both internally and externally. If you are ready to take the helm of a world-class regulatory function and drive the success of a mission-driven organization, we invite you to apply.
Key Responsibilities of Head of Regulatory Affairs with a Medical Device Co. – San Diego, CA
The Head of Regulatory Affairs will have a broad range of responsibilities, encompassing strategic planning, team leadership, and hands-on execution. Success in this role will be measured by the ability to secure timely product approvals, maintain a state of continuous compliance, and provide strategic counsel to the executive team.
Global Regulatory Strategy Development
Develop, implement, and lead forward-thinking global regulatory strategies for new and modified products, ensuring alignment with business objectives. Provide expert regulatory input for product lifecycle planning, from initial design and development through to commercialization and post-market activities.
Regulatory Submissions and Approvals
Oversee and direct the preparation, submission, and maintenance of all regulatory applications and filings. This includes, but is not limited to, Premarket Notifications (510(k)), Premarket Approvals (PMA), Investigational Device Exemptions (IDEs), De Novo requests, EU technical files/design dossiers for CE Marking under MDR, and other international registrations.
Agency Interaction and Communication
Serve as the primary point of contact with all regulatory bodies, including the FDA, Notified Bodies, and other competent authorities. Lead and manage all negotiations and communications with these agencies, fostering positive and productive relationships. Prepare teams for and lead agency meetings, inspections, and audits.
Compliance and Quality System Oversight
Partner closely with the Head of Quality to ensure the company’s Quality Management System (QMS) is robust and compliant with all applicable regulations, including the FDA’s Quality System Regulation (QSR) and ISO 13485. Provide regulatory oversight for labeling, advertising, and promotional materials to ensure compliance.
Post-Market Surveillance and Vigilance
Establish and manage effective post-market surveillance, vigilance, and adverse event reporting systems. Oversee the assessment of product changes for regulatory impact and ensure all necessary filings are completed. Manage product recalls or field actions, if necessary, in coordination with regulatory agencies.
Leadership and Team Development
Build, lead, and mentor a high-performing regulatory affairs team. Foster a culture of excellence, collaboration, and continuous learning. Provide guidance and training to the team and the broader organization on new and evolving regulatory requirements.
Cross-Functional Collaboration
Act as a key strategic partner to R&D, Clinical Affairs, Quality Assurance, Operations, and Commercial teams. Provide critical regulatory intelligence and guidance to support new product development, clinical trial design, and go-to-market strategies.
Regulatory Intelligence and Due Diligence
Monitor, analyze, and interpret the evolving global regulatory landscape. Communicate potential impacts to the business and proactively develop strategies to address new or changing requirements. Support business development activities by providing regulatory due diligence for potential acquisitions or partnerships.
Requirements for the Head of Regulatory Affairs with a Medical Device Co. – San Diego, CA
We are seeking a distinguished professional with a proven track record of success in leading regulatory affairs for medical device companies. The following qualifications are essential for this role:
Educational Background
A minimum of a Bachelor’s degree in a scientific, engineering, or related field is required. An advanced degree (MS, PhD, or MD) is highly preferred.
Professional Experience
A minimum of 15 years of progressive experience in Regulatory Affairs within the medical device industry, with at least 7 years in a significant leadership or management capacity.
Device Experience
Extensive, hands-on experience with Class II and/or Class III medical devices is mandatory. Experience with software as a medical device (SaMD), combination products, or capital equipment is highly advantageous.
Global Regulatory Expertise
Demonstrated success in securing product approvals and managing the product lifecycle in key global markets, including the US (FDA) and Europe (MDR). Experience with other markets such as Canada, Japan, China, or Australia is a strong plus.
Agency Interaction
Proven track record of successful, direct interaction and negotiation with the FDA (CDRH) and EU Notified Bodies. Experience leading FDA inspections is required.
Leadership and Management Skills
Exceptional leadership capabilities with demonstrated success in building and developing high-performing teams. Must possess strong strategic thinking, problem-solving, and decision-making skills.
Communication Skills
Outstanding written and verbal communication skills. The ability to articulate complex regulatory concepts to a variety of audiences, from engineers to the Board of Directors, is critical.
Certifications
Regulatory Affairs Certification (RAC) is highly desirable.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier talent by offering a highly competitive compensation and benefits package, including:
Competitive Compensation
A generous base salary, annual performance-based bonus, and a significant equity/stock option package.
Comprehensive Health and Wellness
Premier medical, dental, and vision insurance plans for you and your dependents. Health Savings Account (HSA) and Flexible Spending Account (FSA) options.
Retirement Planning
A 401(k) retirement plan with a strong company match.
Work-Life Balance
A generous paid time off (PTO) policy, including vacation, sick leave, and paid company holidays.
Professional Development
A substantial budget for continuous learning, including conferences, certifications, and advanced training.
Relocation Assistance
A comprehensive relocation package is available for exceptional candidates.
On-Site Amenities
A modern and collaborative work environment in a prime San Diego location, featuring on-site fitness facilities, catered lunches, and a fully stocked kitchen.
How to Apply
JRG Partners is the exclusive recruitment partner for this confidential search. To be considered for this pivotal leadership role, please submit your resume and a cover letter outlining your qualifications and interest. We are committed to a transparent and efficient interview process. All inquiries and applications will be handled with the utmost confidentiality.
Explore more opportunities and learn about our specialized recruitment services by visiting JRG Partners’ Medical Device & Diagnostics Practice. We look forward to connecting with you and discussing how you can make a significant impact with our innovative client.
