Role Overview for VP, Quality Regulatory with a Medical Device Company – Minneapolis, MN
JRG Partners is proud to partner with a pioneering medical device company at the forefront of innovation in Minneapolis, MN. We are conducting an executive search for a visionary and strategic Vice President of Quality & Regulatory. This is a paramount leadership role responsible for architecting and executing the global quality and regulatory strategy, ensuring the highest standards of product safety, efficacy, and compliance across the entire product lifecycle. The successful candidate will be a key member of the executive leadership team, providing critical guidance that directly impacts the company’s strategic objectives, market access, and long-term growth.
This position demands a leader who can navigate the complex and dynamic landscape of global medical device regulations while fostering a robust culture of quality that permeates every facet of the organization. You will be responsible for building, leading, and mentoring a high-performing team, driving continuous improvement initiatives, and serving as the primary liaison with regulatory bodies such as the FDA, Notified Bodies, and other international health authorities.
Your expertise will be instrumental in bringing next-generation medical technologies to market, improving patient outcomes, and solidifying our client’s position as an industry leader. This is a unique opportunity to make a significant impact within a fast-paced, innovative environment located in the heart of one of the world’s most prominent med-tech hubs.
Key Responsibilities of VP, Quality & Regulatory with a Medical Device Company – Minneapolis, MN
The VP of Quality & Regulatory will have a broad and impactful scope of responsibilities, including but not limited to:
Strategic Leadership & Vision
- Develop, implement, and communicate a comprehensive global quality and regulatory affairs vision and strategy that aligns with the company’s business goals and product pipeline.
- Serve as a strategic advisor to the CEO and executive team on all matters related to quality assurance, regulatory compliance, and risk management.
- Proactively monitor the evolving global regulatory landscape, anticipate changes, and develop strategies to ensure seamless compliance and competitive advantage.
- Establish and manage departmental budgets, resource allocation, and long-range planning to support organizational growth.
- Champion a culture of quality excellence, accountability, and continuous improvement throughout the entire organization, from R&D to post-market surveillance.
Quality Management System (QMS) Oversight
- Assume ultimate responsibility for the establishment, maintenance, and effectiveness of the company’s Quality Management System to ensure compliance with all applicable standards.
- Ensure the QMS is compliant with key regulations and standards, including the FDA’s Quality System Regulation (21 CFR Part 820), ISO 13485, EU MDR/IVDR, and other relevant international requirements.
- Oversee all aspects of the QMS, including but not limited to CAPA, complaint handling, document control, internal audits, management reviews, and supplier quality management.
- Drive initiatives to enhance the efficiency and effectiveness of the QMS, leveraging data analytics and best practices to identify areas for improvement.
Global Regulatory Strategy & Submissions
- Lead the development and execution of innovative and efficient regulatory strategies for new product introductions and product modifications in key markets (US, EU, Canada, etc.).
- Oversee the preparation, submission, and maintenance of all regulatory filings, including 510(k)s, PMAs, De Novo petitions, CE Mark technical files, and other international dossiers.
- Serve as the primary point of contact and lead negotiator with the FDA, Notified Bodies, and other global regulatory agencies.
- Provide regulatory guidance to cross-functional teams, including R&D, Clinical Affairs, and Marketing, throughout the product development lifecycle to ensure regulatory requirements are integrated from conception.
Compliance, Audits, and Post-Market Activities
- Direct and manage all internal and external audits, including FDA inspections, Notified Body audits, and partner audits, ensuring successful outcomes.
- Oversee the company’s post-market surveillance and vigilance programs, including the timely investigation and reporting of adverse events and product complaints.
- Ensure all product labeling, advertising, and promotional materials are in full compliance with applicable regulations.
- Manage and direct any necessary product recalls, field actions, or corrections in a timely and compliant manner.
Requirements for the VP, Quality & Regulatory with a Medical Device Company – Minneapolis, MN
Required Qualifications & Experience
- A minimum of a Bachelor’s degree in Engineering, Life Sciences, or a related technical field. An advanced degree (MS, PhD, or MBA) is highly preferred.
- A minimum of 15 years of progressive experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
- At least 7-10 years of experience in a senior leadership role, with a proven track record of building, managing, and developing high-performing teams.
- Demonstrated, in-depth expertise in global medical device regulations, including FDA 21 CFR 820, 803, 806; ISO 13485; EU MDR (2017/745); and risk management standard ISO 14971.
- Extensive hands-on experience with regulatory submissions for various device classes (Class II and Class III preferred), including 510(k), PMA, and CE marking.
- Proven experience successfully leading companies through FDA inspections and Notified Body audits.
Desired Skills & Competencies
- Exceptional strategic thinking and problem-solving skills with the ability to translate complex regulations into actionable business strategies.
- Outstanding leadership and interpersonal skills; ability to influence, collaborate, and build consensus across all levels and functions of an organization.
- Excellent written and verbal communication skills, with the ability to effectively present complex information to executive leadership, regulatory agencies, and internal teams.
- Strong business acumen and the ability to operate effectively in a fast-paced, dynamic, and results-oriented environment.
- High ethical standards, integrity, and a deep commitment to patient safety and product quality.
- Regulatory Affairs Certification (RAC) is a significant plus.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a highly competitive and comprehensive compensation and benefits package. This includes:
Competitive Executive Compensation
A compelling base salary complemented by a significant annual performance-based bonus.
Equity Participation
Meaningful long-term incentives through stock options or other equity grants, allowing you to share in the company’s success.
Comprehensive Health & Wellness
Premium medical, dental, and vision insurance plans for you and your dependents.
Retirement Savings
A robust 401(k) plan with a generous company match to help you plan for your future.
Generous Paid Time Off
A flexible and generous PTO policy, including vacation, sick leave, and paid company holidays.
Professional Development
A dedicated budget for continuous learning, including conferences, certifications, and executive coaching.
Relocation Assistance
A comprehensive relocation package is available for exceptional candidates moving to the vibrant Minneapolis area.
How to Apply
JRG Partners is a leader in executive search and recruitment for the life sciences sector. We specialize in connecting exceptional leaders with transformative opportunities in the medical device, pharmaceutical, and biotech industries.
If you are a strategic Quality and Regulatory leader with the experience and passion to drive excellence in a cutting-edge medical device company, we encourage you to apply. Please submit your resume and a cover letter detailing your qualifications and interest in the role. All applications will be treated with the strictest confidence.
To learn more about our expertise and to submit your application for this confidential search, please visit our Medical Device Recruiting Practice Area page. We look forward to reviewing your credentials and discussing this exciting opportunity with you.
