Role Overview for VP Regulatory Affairs, Medical Devices – Minneapolis, MN
JRG Partners is proud to partner with a trailblazing, high-growth medical device company based in the vibrant tech hub of Minneapolis, MN. We are seeking an exceptional, strategic, and results-driven leader to join their executive team as the Vice President of Regulatory Affairs. This is a paramount role for an individual passionate about innovation, patient safety, and bringing life-changing medical technologies to the global market. The successful candidate will be the principal architect of the company’s global regulatory strategy, providing the vision and leadership necessary to navigate the complex and ever-evolving landscape of medical device regulations. You will be instrumental in shaping the company’s future, ensuring that its innovative product pipeline achieves timely and successful regulatory approvals in key markets worldwide.
This executive position reports directly to the Chief Executive Officer and is a critical member of the senior leadership team. You will be responsible for building and mentoring a world-class regulatory affairs department, fostering a culture of compliance, quality, and strategic partnership across the organization. Your expertise will directly influence product development lifecycles, clinical trial strategies, and international expansion plans. This is not merely a compliance function; it is a strategic business partnership that drives commercial success. You will be the company’s 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. If you are a seasoned regulatory affairs professional with a proven track record of success in the medical device industry and a desire to make a significant impact within a dynamic and innovative organization, we invite you to apply for this career-defining opportunity.
Key Responsibilities of VP Regulatory Affairs, Medical Devices – Minneapolis, MN
As the Vice President of Regulatory Affairs, you will be entrusted with the comprehensive oversight of all regulatory activities. Your responsibilities will be broad and impactful, requiring a blend of strategic foresight, tactical execution, and inspirational leadership. Key duties include:
Strategic Leadership & Global Vision
- Develop, articulate, and execute a forward-thinking global regulatory strategy that is fully aligned with the company’s commercial goals, product pipeline, and long-term vision.
- Serve as the chief regulatory advisor to the executive leadership team and Board of Directors, providing expert guidance on regulatory risks, opportunities, and changes in the global regulatory environment.
- Proactively monitor the international regulatory landscape, anticipating changes in regulations and standards (e.g., FDA guidance, EU MDR/IVDR, ISO standards) and developing strategies to adapt and maintain compliance.
- Provide regulatory due diligence and strategic input for potential mergers, acquisitions, and licensing agreements to support corporate growth initiatives.
Regulatory Submissions & Agency Interaction
- Direct and oversee the planning, preparation, and submission of all regulatory applications to global health authorities. This includes, but is not limited to, 510(k) Premarket Notifications, Premarket Approvals (PMAs), Investigational Device Exemptions (IDEs), De Novo requests, and CE Mark Technical Files under EU MDR.
- Act as the primary correspondent and negotiator with regulatory agencies. Lead and prepare teams for meetings, teleconferences, and formal presentations with the FDA, Notified Bodies, and other competent authorities.
- Ensure that all regulatory submissions are of the highest quality, scientifically sound, and presented in a manner that facilitates timely and favorable reviews.
- Champion the development of robust regulatory arguments and justifications, leveraging clinical data, non-clinical data, and predicate device information to support submissions for novel and complex technologies.
Compliance, Quality Systems & Post-Market Surveillance
- Partner closely with the VP of Quality Assurance to ensure the company’s Quality Management System (QMS) is robust, effective, and compliant with all applicable regulations, including 21 CFR 820, ISO 13485, and other international standards.
- Provide regulatory oversight for all post-market activities, including the review and reporting of adverse events, management of product recalls or field actions, and the development of periodic safety reports.
- Oversee the review and approval of all product labeling, promotional materials, and advertising to ensure full compliance with regulatory requirements and approved claims.
- Lead the preparation and management of regulatory agency inspections and audits, serving as the primary host and ensuring successful outcomes.
Cross-Functional Collaboration & Team Development
- Build, lead, and mentor a high-performing regulatory affairs team, fostering a culture of excellence, accountability, and continuous professional development.
- Collaborate seamlessly with R&D, Clinical Affairs, Quality, and Operations teams from the earliest stages of product development to provide critical regulatory input and ensure ‘design for compliance’.
- Provide regulatory guidance to clinical teams on study design, endpoints, and data requirements needed to support successful regulatory submissions.
- Work with Marketing and Commercial teams to develop global product launch plans that are synchronized with anticipated regulatory approval timelines.
Requirements for the VP Regulatory Affairs, Medical Devices – Minneapolis, MN
We are seeking a candidate with a distinguished career in medical device regulatory affairs, characterized by progressive leadership and a history of significant accomplishments.
Required Qualifications:
- A minimum of a Bachelor’s degree in a scientific, engineering, or related field. An advanced degree (MS, PhD, MD, or JD) is strongly preferred.
- 15+ years of progressive experience in regulatory affairs within the medical device industry.
- A minimum of 7 years of experience in a senior leadership role, with demonstrated success in building and managing high-performing teams.
- Extensive, hands-on experience with preparing and filing a variety of regulatory submissions, including successful 510(k)s and PMAs for Class II and/or Class III devices.
- In-depth, expert-level knowledge of U.S. Food and Drug Administration (FDA) regulations, EU Medical Device Regulation (MDR 2017/745), ISO 13485, and other key international regulatory requirements.
- Proven track record of successful direct interaction and negotiation with the FDA, Notified Bodies, and other global regulatory authorities.
- Exceptional strategic thinking, problem-solving, and analytical skills with the ability to translate complex regulatory requirements into actionable business strategies.
- Outstanding communication, presentation, and interpersonal skills, with the ability to influence and build consensus among a wide range of internal and external stakeholders.
Preferred Qualifications:
- Regulatory Affairs Certification (RAC) is highly desirable.
- Experience with active implantable devices, cardiovascular, orthopedic, or software as a medical device (SaMD) is a significant plus.
- Experience in a fast-paced, high-growth startup or mid-sized company environment.
- Experience managing regulatory affairs for a global product portfolio, including submissions in key markets like Japan, China, Canada, and Australia.
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:
Competitive Executive Compensation
A highly attractive base salary commensurate with experience and market standards.
Executive Bonus Program
A significant annual performance-based bonus tied to both individual and company achievements.
Long-Term Incentives
A substantial equity package (stock options or RSUs) to ensure you share in the long-term success you help create.
Comprehensive Health & Wellness
Premium medical, dental, and vision insurance plans for you and your dependents, with low employee contributions. Includes access to wellness programs and mental health resources.
Retirement Savings
A 401(k) plan with a generous company match to help you plan for your future.
Generous Paid Time Off (PTO)
A flexible and generous PTO policy, including vacation, sick days, and company holidays, to support a healthy work-life balance.
Professional Development
A dedicated budget for continuing education, attending industry conferences, and maintaining professional certifications.
Relocation Assistance
A comprehensive relocation package is available for exceptional candidates moving to the Minneapolis area.
Modern Work Environment
A collaborative, state-of-the-art office environment that fosters innovation and teamwork.
How to Apply
This is a retained search being conducted exclusively by JRG Partners. To be considered for this exceptional leadership opportunity, please submit your resume and a cover letter detailing your qualifications 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 the JRG Partners’ Top Regulatory Affairs Executive Recruiters Practice page. We are committed to diversity and inclusion and encourage all qualified individuals to apply. We thank all applicants for their interest; however, only those selected for an interview will be contacted.
