Role Overview for VP Regulatory Affairs, Neurovascular Devices – Minneapolis, MN
JRG Partners is proud to represent a pioneering medical device company at the forefront of neurovascular innovation. Our client, a dynamic and rapidly growing organization based in the heart of Minneapolis’s ‘Medical Alley,’ is dedicated to developing life-saving technologies that address complex cerebrovascular diseases. They are seeking a strategic, results-oriented, and visionary Vice President of Regulatory Affairs to join their executive leadership team. This is a paramount role responsible for shaping and executing the global regulatory strategy that will bring their next generation of neurovascular devices to patients worldwide.
As the Vice President of Regulatory Affairs, you will be more than a functional leader; you will be a strategic partner to the CEO and the entire C-suite. You will provide critical guidance on the global regulatory landscape, ensuring that the company’s product development, clinical, and commercial strategies are built on a foundation of regulatory excellence. Your leadership will directly impact the company’s ability to achieve its ambitious growth targets and solidify its position as a market leader. You will be tasked with building and mentoring a world-class regulatory affairs team, fostering a culture of compliance, collaboration, and proactive problem-solving. This position requires a leader with deep expertise in high-risk medical devices, particularly within the neurovascular or cardiovascular space, and a proven history of successful interactions with global regulatory bodies, including the FDA and EU Notified Bodies. This is a unique opportunity to make a tangible impact on patient care by navigating complex regulatory pathways and bringing groundbreaking therapies to market.
Key Responsibilities of VP Regulatory Affairs, Neurovascular Devices – Minneapolis, MN
Strategic Regulatory Leadership
Develop, articulate, and execute comprehensive global regulatory strategies for a complex portfolio of Class III neurovascular devices, from concept through commercialization and post-market surveillance. Provide strategic counsel to the executive team on regulatory risks, opportunities, and emerging trends to inform long-term business planning.
Executive Team Collaboration
Serve as a key member of the senior leadership team, collaborating closely with R&D, Clinical Affairs, Quality Assurance, Operations, and Commercial teams to ensure regulatory requirements are integrated throughout the entire product lifecycle.
Global Submissions Management
Lead the preparation, submission, and maintenance of all regulatory filings. This includes, but is not limited to, Investigational Device Exemptions (IDEs), Premarket Approval (PMA) applications, 510(k) Premarket Notifications, and international submissions such as EU MDR Technical Files and registrations in key markets like Japan, China, and Canada.
Regulatory Agency Liaison
Act as the primary point of contact and build strong, credible relationships with regulatory agencies worldwide, including the FDA, Notified Bodies, and other competent authorities. Lead all negotiations and communications related to submissions, inspections, and compliance inquiries.
Team Development and Mentorship
Recruit, lead, and develop a high-performing regulatory affairs department. Foster a culture of excellence, accountability, and continuous learning. Provide mentorship and guidance to team members to support their professional growth and ensure departmental success.
Compliance and Quality Systems Oversight
Partner with the Head of Quality to ensure robust quality management systems are in place and maintained in compliance with global regulations, including FDA 21 CFR 820 (QSR), ISO 13485, and EU MDR. Oversee regulatory aspects of audits and inspections.
Post-Market Surveillance
Oversee the company’s post-market regulatory activities, including the management of adverse event reporting (MDRs/Vigilance), product recalls or field actions, and the development of Post-Market Surveillance reports (e.g., PSURs).
Regulatory Intelligence
Monitor the evolving global regulatory landscape, analyze the impact of new or revised regulations and guidance documents, and implement necessary changes to company strategy and procedures to ensure continued compliance and competitive advantage.
Budget and Resource Management
Develop and manage the annual budget for the Regulatory Affairs department, ensuring optimal allocation of resources to meet strategic objectives.
Requirements for the VP Regulatory Affairs, Neurovascular Devices – Minneapolis, MN
Educational Background
A minimum of a Bachelor’s degree in a scientific, engineering, or related discipline is required. An advanced degree (MS, PhD, or JD) is highly preferred.
Professional Experience
A minimum of 15 years of progressive experience in the medical device industry, with at least 7-10 years in a senior regulatory leadership role (Director level or above).
Device-Specific Expertise
Direct and extensive experience with Class III, high-risk medical devices is mandatory. Specific experience in the neurovascular, interventional cardiology, or peripheral vascular field is strongly required.
Global Regulatory Acumen
Demonstrated expertise in developing and executing global regulatory strategies. A proven track record of successful PMA and/or original BLA/NDA approvals with the FDA is essential. Deep, practical knowledge of EU MDR is also required.
Leadership and Influence
Proven ability to lead, manage, and inspire a team of regulatory professionals. Exceptional communication, presentation, and interpersonal skills with the ability to influence and negotiate effectively with internal and external stakeholders, including senior executives and regulatory authorities.
Strategic Mindset
Must be a strategic thinker with the ability to translate complex regulatory requirements into actionable business strategies. Strong analytical and problem-solving skills are critical.
Certifications
Regulatory Affairs Certification (RAC) is highly desirable.
Location
The ability to work on-site at the company’s headquarters in the Minneapolis, MN area is required.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier executive talent and offers a highly competitive and comprehensive compensation and benefits package, including:
Executive Compensation
A competitive base salary complemented by a significant annual performance-based bonus.
Long-Term Incentives
A substantial equity package (stock options or RSUs) to ensure you share in the long-term success of the company.
Comprehensive Health and Wellness
Premium medical, dental, and vision insurance plans for you and your dependents.
Retirement Savings
A robust 401(k) plan with a generous company matching contribution.
Paid Time Off
A generous PTO policy, including vacation, sick leave, and paid company holidays.
Relocation Assistance
A comprehensive relocation package is available for qualified candidates moving to the Minneapolis area.
Professional Development
Support for continuing education, professional certifications, and attendance at key industry conferences.
Work Environment
An innovative, collaborative, and mission-driven culture where your contributions have a direct impact on patient lives.
How to Apply
JRG Partners has been exclusively retained to fill this critical leadership position. We are seeking a transformative regulatory leader with a passion for advancing neurovascular technology and a track record of bringing complex medical devices to market. If you meet the qualifications and are ready to take on this challenging and rewarding role, we encourage you to apply.
Please submit your confidential resume and a cover letter detailing your specific qualifications and accomplishments related to this opportunity. To learn more about our specialized expertise in this sector, please visit the page for JRG Partners’ Medical Device Recruiting practice. We look forward to connecting with you.
