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# VP, Regulatory Compliance with a MedTech Company – St. Louis, MO



JRG Partners is proud to partner with a pioneering medical technology company at the forefront of healthcare innovation. Our client is dedicated to developing and commercializing life-changing medical devices that improve patient outcomes and set new standards in clinical care. With a culture rooted in scientific excellence, collaboration, and integrity, they are expanding their executive leadership team to navigate the complex global regulatory landscape. We are seeking a visionary and strategic leader to join them in St. Louis, MO, as the Vice President of Regulatory Compliance.
This is a unique opportunity to shape the future of a dynamic, growth-oriented organization. The successful candidate will be a key member of the executive team, responsible for providing strategic direction and hands-on leadership for all regulatory affairs and compliance activities worldwide. You will be instrumental in ensuring that the company’s innovative products reach patients globally by developing and executing robust regulatory strategies that are aligned with business objectives.
Role Overview for VP, Regulatory Compliance with a MedTech Company – St. Louis, MO
The Vice President of Regulatory Compliance is a critical executive leadership position responsible for the global regulatory strategy and execution across the entire product lifecycle. This role provides strategic and operational leadership to the regulatory affairs department, ensuring that all products, manufacturing processes, and quality systems are in compliance with applicable international regulations and standards. The VP will serve as the primary contact with regulatory agencies such as the FDA, Notified Bodies, and other international health authorities.
You will be tasked with building and mentoring a high-performing team, fostering a culture of compliance and continuous improvement, and collaborating closely with cross-functional leaders in R&D, Quality, Clinical, and Commercial departments to achieve the company’s strategic goals. Your expertise will directly influence the company’s ability to innovate, achieve timely market access for new products, and maintain an impeccable compliance record in a competitive and highly regulated industry. This position demands a forward-thinking leader who can anticipate regulatory trends, mitigate risks, and champion regulatory excellence as a core business advantage.
Key Responsibilities of VP, Regulatory Compliance with a MedTech Company – St. Louis, MO
Global Regulatory Strategy
Develop, implement, and lead comprehensive global regulatory strategies for new and modified products, from concept through commercialization, ensuring alignment with overall business objectives. This includes creating strategic plans for submissions to the FDA (510(k), PMA, IDE), EU (CE Marking under MDR), and other key international markets.
Team Leadership and Development
Build, mentor, and lead a world-class regulatory affairs team. Foster a collaborative and high-performance culture, providing guidance, professional development opportunities, and performance management to ensure the team has the skills and resources to meet current and future challenges.
Regulatory Submissions and Approvals
Oversee the preparation, submission, and maintenance of all regulatory applications and registrations. Ensure all filings are of the highest quality, scientifically sound, and submitted on schedule to secure timely product approvals.
Health Authority Liaison
Serve as the company’s primary representative 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.
Compliance and Quality Systems Oversight
Ensure ongoing compliance with all applicable regulations and standards, including FDA’s Quality System Regulation (21 CFR 820), ISO 13485, EU Medical Device Regulation (MDR 2017/745), and other global requirements. Partner with the Quality Assurance team to maintain a robust and effective Quality Management System (QMS).
Post-Market Surveillance and Vigilance
Direct all post-market regulatory activities, including the management of adverse event reporting, medical device reporting (MDRs), vigilance reporting, product recalls, and field safety corrective actions, ensuring timely and compliant execution.
Cross-Functional Collaboration
Act as a strategic partner to R&D, Clinical Affairs, Quality, Operations, and Marketing teams. Provide expert regulatory guidance on product design and development, clinical trial design, labeling, promotional materials, and change control processes to ensure regulatory requirements are integrated throughout the product lifecycle.
Regulatory Intelligence
Proactively monitor, interpret, and analyze the global regulatory environment for emerging trends, new regulations, and guidance documents. Assess the impact on the company’s products and strategies and disseminate this intelligence to relevant stakeholders to inform business decisions and mitigate risk. Possessing a comprehensive understanding of global regulatory pathways is essential for success.
Due Diligence and Business Development
Provide regulatory expertise and support for business development activities, including due diligence for potential mergers, acquisitions, and strategic partnerships.
Budget and Resource Management
Develop and manage the departmental budget, ensuring efficient allocation of resources to meet strategic objectives and operational needs.
Requirements for the VP, Regulatory Compliance with a MedTech Company – St. Louis, MO
Educational Background
An advanced degree (M.S., Ph.D., or J.D.) in a scientific, engineering, or legal discipline is strongly preferred. A Bachelor’s degree in a relevant field is required.
Professional Experience
A minimum of 15 years of progressive experience in regulatory affairs within the medical device or MedTech industry, with at least 7 years in a senior leadership role managing a team and setting strategic direction.
Device Expertise
Extensive, hands-on experience with Class II and/or Class III medical devices is required. Experience with software as a medical device (SaMD), combination products, or capital equipment is highly desirable.
Regulatory Knowledge
Deep and current expertise in U.S. FDA regulations (PMA, 510(k), De Novo, QSR), the European Medical Device Regulation (EU MDR), and ISO 13485. Familiarity with regulations in other key markets (e.g., Canada, Japan, China, Australia) is a significant asset.
Proven Track Record
Demonstrated success in leading the development and execution of global regulatory strategies, resulting in timely and successful product approvals and maintaining a strong compliance posture.
Leadership Skills
Exceptional leadership, communication, and interpersonal skills. Proven ability to build and lead high-performing teams, influence executive leadership, and collaborate effectively across a matrixed organization.
Strategic Thinking
Strong strategic and analytical skills with the ability to translate complex regulatory requirements into actionable business strategies and operational plans.
Agency Interaction
Extensive experience as the primary contact with the FDA and other regulatory bodies, with a proven ability to negotiate and resolve complex regulatory issues effectively.
Location
Ability to work on-site at the company headquarters in St. Louis, MO. Relocation assistance is available for the ideal candidate.
Benefits & Perks Offered
Our client is committed to investing in their employees 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 and a long-term equity incentive plan (stock options/RSUs).
Comprehensive Health and Wellness
Premium medical, dental, and vision insurance plans for employees and their families, along with a robust wellness program, and Health Savings Account (HSA) or Flexible Spending Account (FSA) options.
Retirement Savings
A 401(k) retirement plan with a generous company match to help you plan for your future.
Paid Time Off
A generous paid time off (PTO) policy, including vacation, sick leave, and company-paid holidays to support work-life balance.
Professional Development
A strong commitment to your growth with support for continuing education, industry conferences, and professional certifications.
Relocation Assistance
A comprehensive relocation package is available for qualified candidates moving to the St. Louis area.
Additional Perks
Life insurance, short-term and long-term disability coverage, employee assistance programs, and other perks designed to support your well-being.
How to Apply
This is a retained search exclusively managed by JRG Partners. If you are a visionary regulatory leader with a passion for innovation and a proven track record of success in the medical device industry, we invite you to apply for this transformative opportunity. To be considered, please submit your resume and a cover letter detailing your qualifications and strategic accomplishments. For more information on our expertise in this sector, please visit the JRG Partners’ Medical Device & Technology practice page. We look forward to connecting with you to discuss how you can make a lasting impact with our client.