Role Overview for VP Quality & Regulatory, Orthopedic Devices – Minneapolis, MN
JRG Partners is proud to partner with a pioneering, high-growth orthopedic device company based in the vibrant medical technology hub of Minneapolis, MN. We are seeking a visionary and strategic Vice President of Quality & Regulatory Affairs to join their executive leadership team. This is a paramount role for an individual passionate about innovation, patient safety, and shaping the future of orthopedic care. Reporting directly to the Chief Executive Officer, you will be the ultimate authority on all quality and regulatory matters, providing the strategic direction necessary to navigate the complex global landscape of medical device compliance.
The successful candidate will be a hands-on, yet strategic leader responsible for architecting, implementing, and maintaining a best-in-class global quality management system (QMS) and regulatory strategy. You will lead a talented team of professionals, fostering a culture of continuous improvement, compliance, and excellence. This position is critical to the company’s success, ensuring that our innovative orthopedic products not only meet but exceed the most stringent international standards, from initial concept through to commercialization and post-market surveillance. You will be the primary liaison with regulatory bodies such as the FDA, Notified Bodies, and other international health authorities, safeguarding the company’s reputation and enabling its ambitious growth trajectory. If you are an experienced leader with a proven track record of bringing complex orthopedic devices to market globally, we invite you to apply for this transformative opportunity.
Key Responsibilities of VP Quality & Regulatory, Orthopedic Devices – Minneapolis, MN
As the Vice President of Quality & Regulatory, you will be entrusted with the comprehensive oversight of the company’s compliance framework. Your duties will be broad and impactful, including:
Strategic Leadership
Develop and execute a forward-thinking global regulatory and quality strategy that aligns with the company’s business objectives, product pipeline, and market expansion goals. Provide critical counsel to the executive team and Board of Directors on regulatory risks, opportunities, and changes in the global regulatory environment.
Global Regulatory Submissions
Direct and oversee the preparation, submission, and maintenance of all regulatory applications and registrations, including FDA 510(k)s, PMAs, De Novo petitions, and international filings under regulations such as the EU Medical Device Regulation (MDR).
Quality Management System (QMS) Oversight
Champion the continuous development, implementation, and maintenance of a robust and efficient QMS compliant with ISO 13485, FDA’s 21 CFR Part 820, and other applicable global standards. Ensure the QMS is effectively integrated across all business functions.
Regulatory Body Interaction
Serve as the primary point of contact and build strong, collaborative relationships with regulatory agencies worldwide, including the FDA, Notified Bodies, and Ministries of Health. Lead and manage all regulatory inspections and audits with confidence and transparency.
Team Development & Management
Lead, mentor, and grow a high-performing team of quality and regulatory affairs professionals. Foster a culture of accountability, collaboration, and professional development, ensuring the team is equipped to meet current and future challenges.
Post-Market Surveillance & Vigilance
Oversee all post-market activities, including complaint handling, Medical Device Reporting (MDRs), vigilance reporting, and recalls. Ensure timely and effective analysis of post-market data to drive product improvements and maintain compliance.
Design Control & Risk Management
Provide expert quality and regulatory guidance to R&D and product development teams throughout the entire product lifecycle. Ensure robust design controls (21 CFR 820.30) and risk management processes (ISO 14971) are effectively implemented.
Supplier Quality Management
Direct the supplier quality program, including supplier evaluation, qualification, auditing, and performance monitoring to ensure the integrity and compliance of the entire supply chain.
Cross-Functional Collaboration
Work seamlessly with other department heads—including R&D, Clinical Affairs, Operations, and Marketing—to ensure regulatory and quality requirements are understood and integrated into all company processes and strategic initiatives.
Budget & Resource Planning
Develop and manage the departmental budget, ensuring optimal allocation of resources to achieve strategic objectives efficiently and effectively.
Requirements for the VP Quality & Regulatory, Orthopedic Devices – Minneapolis, MN
We are looking for a seasoned professional who combines deep technical expertise with exceptional leadership qualities. The ideal candidate will meet the following qualifications:
Educational Background
A minimum of a Bachelor’s degree in Engineering, Life Sciences, or a related technical field is required. An advanced degree (MS, PhD, or MBA) is highly preferred.
Executive Experience
A minimum of 15 years of progressive experience in Quality and/or Regulatory Affairs within the medical device industry, with at least 7 years in a senior leadership role (Director level or above).
Orthopedic Device Expertise
Extensive, direct experience with Class II and/or Class III orthopedic devices (e.g., joint replacements, spinal implants, trauma products) is mandatory.
Regulatory Mastery
Demonstrated expertise in navigating complex global regulations, including extensive, hands-on experience with FDA 510(k) and PMA submission processes, as well as the EU MDR. Experience with other key markets (e.g., Japan, Canada, Australia) is a significant asset.
QMS Proficiency
In-depth knowledge and practical application of quality system standards, including ISO 13485 and 21 CFR Part 820. Proven experience building, scaling, and improving quality systems in a growing organization.
Proven Leadership
A track record of successfully building, leading, and mentoring high-performing teams. Must possess excellent interpersonal, communication, and presentation skills, with the ability to influence and engage stakeholders at all levels, from engineers to the Board of Directors.
Audit & Inspection Management
Verifiable experience successfully leading and managing FDA inspections, Notified Body audits, and other regulatory agency audits.
Strategic Acumen
Strong strategic thinking and problem-solving skills, with the ability to translate complex regulatory requirements into actionable business strategies.
Certifications
Regulatory Affairs Certification (RAC) is highly desirable.
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 complemented by a significant annual performance-based bonus.
Long-Term Incentives
A meaningful equity/stock option package that allows you to share in the long-term success of the company.
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 Time Off
A flexible and generous paid time off (PTO) policy, in addition to company-paid holidays.
Relocation Assistance
A comprehensive relocation package is available for the right candidate to move to the dynamic Minneapolis area.
Professional Growth
Support for continuous learning, professional development, and participation in key industry conferences.
Innovative Culture
An opportunity to work in a fast-paced, collaborative, and mission-driven environment where your contributions directly impact patient outcomes.
How to Apply
If you are a driven leader ready to make a significant impact in the orthopedic device industry, we encourage you to apply for this exciting opportunity. JRG Partners specializes in connecting exceptional talent with leading companies in the life sciences sector. To be considered, please submit your resume and a cover letter detailing your qualifications and experience.
For more information on our expertise and other opportunities, please visit our Medical Device Recruiting practice area. We look forward to reviewing your application.
