Role Overview for Chief Regulatory Officer – San Francisco, CA
JRG Partners is proud to partner with a pioneering, venture-backed medical device company based in the vibrant innovation hub of San Francisco, CA. Our client is at the forefront of developing transformative technologies that address critical unmet needs in patient care. They are seeking a visionary and strategic Chief Regulatory Officer (CRO) to join their executive leadership team. This is a paramount role responsible for architecting and executing a comprehensive global regulatory strategy that will guide the company’s innovative products from conception to commercialization and beyond.
As the Chief Regulatory Officer, you will be the principal architect of the company’s regulatory landscape. You will provide the strategic direction and hands-on leadership necessary to navigate the complex and dynamic regulatory environments in the United States, Europe, and other key international markets. This position requires a leader with exceptional foresight, deep expertise in medical device regulations, and a proven track record of successful product approvals.
You will serve as the primary liaison with regulatory bodies such as the FDA, Notified Bodies, and other international health authorities, building and maintaining relationships founded on trust and transparency. Your guidance will be critical in shaping product development, clinical trial strategies, and quality management systems to ensure unwavering compliance and accelerate market access. This is a unique opportunity to make a significant impact on a rapidly growing organization and, ultimately, on the lives of patients worldwide.
The ideal candidate is not just a regulatory expert but also a strategic business partner. You will collaborate closely with the CEO, CTO, and other C-suite executives to align regulatory milestones with corporate objectives. You will be responsible for building, mentoring, and leading a high-performing regulatory affairs team, fostering a culture of excellence, integrity, and proactive problem-solving. Your ability to interpret evolving regulatory trends and translate them into actionable strategies will be crucial for maintaining the company’s competitive edge. If you are a driven leader passionate about bringing life-changing medical technologies to market and thrive in a fast-paced, innovative environment, we invite you to apply for this career-defining role.
Key Responsibilities of Chief Regulatory Officer – San Francisco, CA
Global Regulatory Strategy
Develop, implement, and lead the company’s global regulatory strategy for a diverse portfolio of medical devices, including Class II and Class III devices, as well as Software as a Medical Device (SaMD). Ensure regulatory strategies are aligned with business objectives, timelines, and budget.
Regulatory Submissions
Direct and oversee the preparation, submission, and maintenance of all regulatory applications and filings, including Pre-Submissions, Investigational Device Exemptions (IDEs), 510(k)s, De Novo requests, and Premarket Approvals (PMAs) in the US, as well as Technical Files/Design Dossiers for CE Marking under EU MDR.
Agency Interaction
Serve as the primary point of contact and lead all communications and negotiations with regulatory agencies worldwide, including the U.S. Food and Drug Administration (FDA), European Notified Bodies, and other competent authorities. Cultivate strong, positive relationships with agency representatives.
Lifecycle Management
Provide regulatory oversight throughout the entire product lifecycle, from initial concept and design control through post-market surveillance, complaint handling, vigilance reporting, and product recalls if necessary.
Cross-Functional Leadership
Act as a key strategic partner to R&D, Clinical Affairs, Quality Assurance, and Marketing teams. Provide expert regulatory guidance on design controls, risk management (ISO 14971), clinical study design, labeling, and promotional materials to ensure compliance.
Regulatory Intelligence
Proactively monitor, analyze, and interpret the evolving global regulatory landscape. Disseminate critical intelligence to the executive team and relevant departments, and adapt strategies accordingly to mitigate risk and capitalize on opportunities.
Team Development
Recruit, train, mentor, and lead a world-class regulatory affairs organization. Foster a collaborative and high-performance culture, setting clear goals and providing the resources necessary for success.
QMS Compliance
Collaborate with the Head of Quality to ensure the company’s Quality Management System (QMS) is robust, effective, and compliant with all applicable regulations and standards, including 21 CFR 820 (QSR), ISO 13485, and EU MDR.
Due Diligence
Provide regulatory expertise and support for potential M&A, licensing, and partnership activities, assessing regulatory risks and opportunities of target assets.
Requirements for the Chief Regulatory Officer – San Francisco, CA
Educational Background
An advanced degree (M.S., Ph.D., or equivalent) in a scientific, engineering, or health-related discipline is required. A Regulatory Affairs Certification (RAC) is highly desirable.
Executive Experience
A minimum of 15 years of progressive experience in the medical device industry, with at least 7 years in a senior regulatory leadership role (Director, VP, or higher). Prior experience as a CRO or VP of Regulatory Affairs is strongly preferred.
Proven Track Record
Demonstrated success in obtaining market clearance and approval for complex medical devices (Class II and/or Class III) in the US and EU. A history of successful negotiations with the FDA and Notified Bodies is essential.
Regulatory Expertise
Deep and comprehensive knowledge of US FDA regulations (21 CFR Parts 803, 806, 820), the EU Medical Device Regulation (MDR 2017/745), and other key international regulatory requirements (e.g., Canada, Japan, Australia).
Technical Acumen
Strong understanding of medical device development processes, including design controls, risk management, clinical evaluation, and quality management systems (ISO 13485). Experience with SaMD, AI/ML-enabled devices, or combination products is a significant plus.
Leadership Skills
Exceptional leadership, communication, and interpersonal skills. The ability to influence and align stakeholders across all levels of the organization, from the board of directors to project teams.
Strategic Mindset
Must be a strategic thinker with the ability to balance regulatory requirements with business goals. Proven ability to develop creative and compliant regulatory pathways for novel technologies.
Location
Ability to work on-site at the company’s headquarters in San Francisco, CA. A hybrid work model may be considered for the right candidate.
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 member of the executive team, you can expect:
Executive Compensation
A highly competitive base salary complemented by a significant annual performance-based bonus.
Meaningful Equity
A substantial equity grant (stock options) to ensure you share directly in the company’s long-term success.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your dependents with low employee contributions.
Retirement Savings
A 401(k) plan with a generous company matching program to help you plan for your future.
Work-Life Balance
A generous paid time off (PTO) policy, paid company holidays, and flexible scheduling to support a healthy work-life integration.
Professional Growth
A dedicated budget for continuous learning, professional development, conferences, and certifications to keep you at the top of your field.
Wellness Programs
Company-sponsored wellness initiatives, including gym memberships, mental health resources, and healthy office snacks and beverages.
Relocation Support
A comprehensive relocation package is available for exceptional candidates moving to the San Francisco Bay Area.
How to Apply
This is an exclusive search being conducted by JRG Partners. To be considered for this exceptional opportunity, please submit your resume and a cover letter detailing your relevant experience and strategic accomplishments. We encourage you to apply promptly as we are actively reviewing candidates. For more information about our expertise in this sector, please visit our page on our work as life sciences executive search specialists. JRG Partners and our client are Equal Opportunity Employers. We celebrate diversity and are committed to creating an inclusive environment for all employees.
