JRG Partners is proud to partner with a pioneering, publicly-traded medical device company headquartered in St. Louis, MO, dedicated to revolutionizing patient care through groundbreaking technology. With a robust portfolio of life-sustaining and life-enhancing devices, they are a market leader in their therapeutic area. Their culture is built on a foundation of innovation, integrity, and a relentless pursuit of excellence. As they embark on their next phase of global expansion and product pipeline development, they are seeking a visionary and strategic leader to join their executive team as the Vice President of Regulatory Compliance.
Role Overview for VP, Regulatory Compliance with a Medical Device Co. – St. Louis, MO
The Vice President of Regulatory Compliance is a cornerstone of the executive leadership team, reporting directly to the Chief Executive Officer. This individual will be the ultimate authority on all global regulatory matters, providing strategic direction and hands-on leadership to ensure the company’s products meet and exceed the stringent requirements of regulatory bodies worldwide. This role is not merely about compliance; it’s about creating a strategic advantage by navigating the complex and ever-evolving regulatory landscape with foresight and agility.
The VP will be instrumental in shaping the company’s long-term strategy, influencing product development lifecycles from concept to commercialization, and building a world-class regulatory affairs organization. This is a unique opportunity to make a significant impact on a growing company at the forefront of medical technology, based in the vibrant hub of St. Louis.
You will be the primary liaison with regulatory agencies like the FDA, Notified Bodies, and other international health authorities, representing the company with the highest level of professionalism and expertise. Your leadership will ensure that the path to market for new innovations is both efficient and impeccably compliant, directly contributing to the company’s growth and its mission to improve patient outcomes globally.
Key Responsibilities of VP, Regulatory Compliance with a Medical Device Co. – St. Louis, MO
The VP of Regulatory Compliance will have a broad and impactful scope of responsibilities, including but not limited to:
Strategic Leadership & Global Vision
- Develop and execute a comprehensive global regulatory strategy that aligns with the company’s business objectives, product pipeline, and long-term growth plans.
- Serve as a key member of the executive team, providing critical regulatory insights and risk assessments to inform strategic decisions, including M&A activities, new market entry, and portfolio management.
- Monitor, interpret, and communicate changes in the global regulatory environment (e.g., FDA guidance, EU MDR/IVDR, MDSAP) and proactively develop strategies to adapt and maintain compliance.
- Establish and maintain strong, positive relationships with key regulatory agencies (FDA, Health Canada, EU Notified Bodies, etc.), acting as the primary senior-level contact.
Regulatory Submissions & Approvals
- Oversee the preparation, submission, and maintenance of all regulatory applications and registrations, including Premarket Approvals (PMAs), 510(k)s, Investigational Device Exemptions (IDEs), and international dossiers/technical files.
- Provide expert guidance to R&D and product development teams on regulatory requirements from early-stage concept through to post-market, ensuring ‘design for compliance’ principles are integrated into the product lifecycle.
- Lead negotiations and communications with regulatory agencies to resolve complex issues and facilitate timely review and approval of submissions.
- Manage and direct all activities related to clinical trial regulatory compliance, ensuring studies are conducted in accordance with GCP and applicable regulations.
Quality System & Compliance
- Partner closely with the VP of Quality Assurance to ensure the company’s Quality Management System (QMS) is robust, effective, and in full compliance with global standards.
- Ensure full adherence to the FDA’s Quality System Regulation (21 CFR Part 820), ISO 13485, and other relevant standards across the entire organization.
- Lead the organization through regulatory inspections and audits by the FDA, Notified Bodies, and other authorities, managing all aspects of preparation, execution, and response.
- Oversee the regulatory review and approval of all product labeling, advertising, and promotional materials to ensure they are truthful, non-misleading, and compliant with all applicable regulations.
Post-Market Surveillance & Vigilance
- Direct the company’s post-market surveillance and vigilance programs, including the management of adverse event reporting (MDRs), complaint handling, and recall strategies.
- Ensure timely and accurate reporting to all relevant regulatory authorities worldwide in the event of reportable incidents or field safety corrective actions.
- Utilize post-market data to inform risk management activities, product improvements, and updates to regulatory submissions.
Team Leadership & Development
- Lead, mentor, and develop a high-performing global regulatory affairs team, fostering a culture of excellence, collaboration, and continuous learning.
- Establish clear goals and performance metrics for the department, ensuring the team is structured and resourced appropriately to meet the company’s needs.
- Champion professional development within the team, ensuring they remain at the forefront of regulatory intelligence and best practices.
Requirements for the VP, Regulatory Compliance with a Medical Device Co. – St. Louis, MO
The ideal candidate will be a seasoned and strategic regulatory professional with a proven track record of success in the medical device industry.
Educational & Professional Experience
- An advanced degree (M.S., Ph.D., J.D., or M.D.) in a scientific, engineering, or related field is highly preferred. A Bachelor’s degree in a relevant discipline is required.
- A minimum of 15 years of progressive experience in regulatory affairs within the medical device industry.
- A minimum of 7 years in a senior leadership capacity, with demonstrated experience building and managing high-performing global teams.
- Extensive experience with Class II and/or Class III medical devices is mandatory. Experience with active implantable, software as a medical device (SaMD), or combination products is highly desirable.
- Regulatory Affairs Certification (RAC) is a strong plus.
Technical Skills & Knowledge
- Deep, expert-level knowledge of U.S. FDA regulations (PMA, 510(k), IDE, QSR), European regulations (MDR/IVDR, CE Marking), and other key international regulatory systems (e.g., Canada, Japan, China).
- Proven track record of successful regulatory submissions and obtaining market clearance/approval for complex medical devices in major global markets.
- Demonstrated experience leading companies through successful FDA inspections and Notified Body audits.
- Strong understanding of quality management systems (ISO 13485), risk management (ISO 14971), and clinical evaluation requirements.
Leadership & Interpersonal Skills
- Exceptional strategic thinking and problem-solving abilities, with the capacity to navigate ambiguity and make sound judgments under pressure.
- Outstanding communication skills (written, verbal, and presentation), with the ability to articulate complex regulatory concepts to diverse audiences, from engineers to the Board of Directors.
- Proven ability to influence and collaborate effectively across all levels and functions of an organization.
- Unquestionable integrity, ethics, and a strong commitment to patient safety and product quality.
Benefits & Perks Offered
Our client offers a highly competitive executive compensation package and a comprehensive benefits program designed to support the well-being of their employees and their families. This includes:
- Executive Compensation: A highly competitive base salary, annual performance-based bonus, and a significant long-term incentive plan (equity/stock options).
- Comprehensive Health Coverage: Premier medical, dental, and vision insurance plans with low employee contributions.
- Retirement Savings: A generous 401(k) plan with a strong company match to help you plan for your future.
- Work-Life Balance: A substantial Paid Time Off (PTO) policy, paid company holidays, and flexible work arrangements.
- Relocation Assistance: A comprehensive relocation package is available for qualified candidates and their families to move to the St. Louis area.
- Professional Growth: A significant budget for professional development, including conferences, certifications, and advanced training.
- Wellness Programs: Company-sponsored wellness initiatives, gym membership reimbursements, and access to mental health resources.
- Additional Perks: Life insurance, disability coverage, employee assistance program, and other perks befitting an executive-level role.
How to Apply
If you are a visionary regulatory leader ready to shape the future of a dynamic medical device company, we invite you to take the next step in your career. This executive search is being conducted exclusively by JRG Partners on behalf of our esteemed client.
To be considered for this confidential search, please submit your resume and a cover letter outlining your qualifications and how your experience aligns with the requirements of this role. All applications will be treated with the utmost confidentiality.
For more information or to explore similar senior-level opportunities within the healthcare and technology sectors, we encourage you to visit the practice page of JRG Partners’ Life Sciences Executive Search team. We look forward to connecting with you.
Our client is an Equal Opportunity Employer and is committed to building a diverse and inclusive workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
