Role Overview for Chief Regulatory Officer – Minneapolis, MN
JRG Partners is proud to partner with a pioneering, high-growth medical device company in the search for an accomplished Chief Regulatory Officer (CRO). Based in the vibrant medical technology hub of Minneapolis, MN, this executive leadership role is critical to the company’s mission of advancing patient care through groundbreaking innovation. The CRO will be the strategic architect of the company’s global regulatory landscape, responsible for guiding novel products from conception to market approval and ensuring sustained compliance across all operational territories.
This is not merely a compliance function; it is a strategic business partnership. The ideal candidate will be a visionary leader who can navigate the complex and evolving global regulatory environment, transforming challenges into competitive advantages. You will serve as the primary interface with regulatory agencies worldwide, including the U.S. Food and Drug Administration (FDA), and build a world-class regulatory affairs organization. Your expertise will directly influence product development pipelines, international expansion strategies, and the overall trajectory of the company.
As a key member of the executive team, you will report directly to the CEO and play an instrumental role in shaping the future of a company poised for significant impact on a global scale. We are seeking a leader who thrives in a dynamic environment, possesses an entrepreneurial spirit, and is passionate about bringing life-changing medical technologies to patients around the world.
Key Responsibilities of Chief Regulatory Officer – Minneapolis, MN
The Chief Regulatory Officer will have a broad and impactful scope of responsibilities, including but not limited to:
Global Regulatory Strategy
Develop, implement, and lead comprehensive global regulatory strategies for new and modified products, ensuring alignment with corporate objectives. Provide strategic guidance to cross-functional teams, including R&D, Clinical Affairs, Quality, and Marketing, from early-stage development through post-market activities.
Regulatory Submissions
Direct and oversee the preparation, submission, and maintenance of all regulatory applications and filings. This includes Premarket Approvals (PMAs), 510(k)s, De Novo requests, Investigational Device Exemptions (IDEs), CE Markings under MDR, and other international registrations.
Agency Liaison
Act as the principal correspondent with global regulatory authorities. Cultivate and maintain strong, positive relationships with agencies such as the U.S. Food and Drug Administration (FDA), Notified Bodies, and other international health ministries. Lead all negotiations and communications related to submissions, inspections, and compliance inquiries.
Team Leadership and Development
Build, mentor, and lead a high-performing regulatory affairs team. Foster a culture of excellence, collaboration, and continuous learning. Establish clear goals, provide regular feedback, and manage departmental resources effectively to meet business demands.
Compliance and Quality Systems
Collaborate closely with the Chief Quality Officer to ensure the company’s Quality Management System (QMS) is robust and compliant with all applicable regulations, including FDA 21 CFR 820 and ISO 13485. Oversee post-market surveillance, vigilance reporting, and adverse event reporting systems.
Regulatory Intelligence
Proactively monitor the global regulatory landscape for changes in laws, regulations, and guidance. Analyze the potential impact on the company’s products and strategies, and effectively communicate this intelligence to the executive team and relevant stakeholders to ensure proactive adaptation.
Executive Counsel
Serve as the subject matter expert on regulatory affairs for the executive leadership team and Board of Directors. Provide insightful counsel on regulatory risks, opportunities, and the potential impact of business decisions on the company’s compliance posture and market access.
Cross-Functional Collaboration
Champion regulatory requirements throughout the product lifecycle. Work seamlessly with R&D to ensure ‘design for compliance,’ support clinical trial design and execution, and partner with commercial teams on labeling, advertising, and promotional material review.
Requirements for the Chief Regulatory Officer – Minneapolis, MN
The successful candidate will be a seasoned executive with a proven track record of regulatory success in the medical device industry.
Educational Background
An advanced degree (M.S., Ph.D., or J.D.) in a scientific, engineering, or legal field is required.
Executive Experience
A minimum of 15 years of progressive experience in medical device regulatory affairs, with at least 7-10 years in a senior leadership capacity managing a team and setting strategic direction.
Device Expertise
Extensive, hands-on experience with Class II and/or Class III medical devices is essential. A strong track record of successful PMA and 510(k) clearances is required. Experience with software as a medical device (SaMD), implantables, or combination products is highly desirable.
Global Acumen
Deep, practical knowledge of U.S. FDA regulations, the EU Medical Device Regulation (MDR), and other key international regulatory systems (e.g., Canada, Japan, China). Experience managing a global product portfolio is critical.
Leadership Skills
Demonstrated ability to lead, influence, and inspire a diverse team. Proven experience in building and scaling a regulatory affairs function to support company growth.
Strategic Thinking
Must be a strategic thinker with the ability to translate complex regulatory requirements into actionable business strategies. Capable of balancing regulatory risk with business objectives.
Communication Prowess
Exceptional written and verbal communication skills. The ability to articulate complex regulatory issues clearly and persuasively to diverse audiences, from engineers to board members to regulatory agents.
Certifications
Regulatory Affairs Certification (RAC) is strongly preferred.
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.
Equity Participation
A substantial equity grant (stock options or RSUs) to ensure you share in the long-term success you help create.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your dependents.
Retirement Savings
A 401(k) plan with a generous company matching contribution.
Generous Paid Time Off
A flexible and generous PTO policy, including company holidays, to support a healthy work-life balance.
Relocation Assistance
A comprehensive relocation package is available for exceptional candidates moving to the Minneapolis area.
Professional Development
A dedicated budget for continuous learning, including conferences, certifications, and executive coaching.
Wellness Programs
Access to wellness initiatives and resources to support your physical and mental well-being.
How to Apply
This is an exclusive search being conducted by JRG Partners. If you are a transformative regulatory leader with the experience and drive to make a significant impact in the medical device industry, we encourage you to apply. To be considered for this confidential opportunity, please submit your resume and a cover letter outlining your qualifications.
JRG Partners is a leader in executive recruitment for the life sciences sector. To learn more about our expertise and explore other opportunities, please visit our Medical Device & Diagnostics Executive Search practice area. We look forward to connecting with you.
