Role Overview for VP, Regulatory Affairs with a Diagnostics Manufacturer – St. Louis, MO
JRG Partners is proud to represent a premier, innovation-driven diagnostics manufacturer in their search for a visionary Vice President of Regulatory Affairs. Our client is at the forefront of developing groundbreaking in vitro diagnostic (IVD) solutions that empower clinicians and improve patient outcomes worldwide. Based in their strategic corporate hub in St. Louis, MO, this executive role is a cornerstone of the senior leadership team, reporting directly to the Chief Executive Officer. This is a rare opportunity to shape the future of diagnostic medicine by architecting and executing a global regulatory strategy that will bring life-saving technologies to market.
The VP of Regulatory Affairs will be the organization’s chief regulatory strategist, responsible for navigating the complex and evolving global regulatory landscape. This individual will provide inspirational leadership to a talented team, foster a culture of compliance and excellence, and serve as the primary liaison with regulatory bodies such as the FDA, EU Notified Bodies, and other international health authorities.
The ideal candidate is a seasoned leader with a profound understanding of the diagnostics industry, a proven track record of successful product approvals, and the strategic acumen to guide the company through its next phase of significant growth. You will be instrumental in ensuring that the company’s innovative products not only meet but exceed the highest standards of safety and efficacy, ultimately impacting public health on a global scale. This role demands a leader who can balance strategic foresight with hands-on execution, driving regulatory initiatives that are seamlessly integrated with the company’s ambitious commercial and R&D objectives.
Key Responsibilities of VP, Regulatory Affairs with a Diagnostics Manufacturer – St. Louis, MO
The Vice President of Regulatory Affairs will have a broad and impactful scope of responsibilities, encompassing strategic leadership, team management, and tactical execution. Success in this role requires a dynamic and proactive approach to managing all facets of the regulatory function.
Global Regulatory Strategy & Executive Leadership
- Develop, articulate, and implement a forward-thinking global regulatory strategy that aligns with the company’s long-term business goals, product pipeline, and target markets.
- Serve as the key regulatory advisor to the executive leadership team, Board of Directors, and key stakeholders, providing critical insights and risk assessments on regulatory trends, challenges, and opportunities.
- Proactively monitor, interpret, and analyze the impact of new or changing regulations, guidances, and standards from around the world (e.g., FDA, EU IVDR, Health Canada, TGA) and translate them into actionable strategies.
- Provide strategic regulatory input for product development, clinical study designs, product lifecycle management, and business development opportunities, including due diligence for potential acquisitions or partnerships.
Regulatory Submissions & Agency Interactions
- Direct and oversee the entire lifecycle of regulatory submissions, ensuring they are of the highest quality, scientifically sound, and submitted on schedule. This includes Pre-Submissions, 510(k)s, De Novo requests, Premarket Approval (PMA) applications, and CE Marking technical documentation under IVDR.
- Act as the primary point of contact and lead negotiator with the FDA, Notified Bodies, and other global regulatory authorities. Cultivate and maintain strong, positive relationships with agency representatives.
- Lead the preparation and execution of formal meetings with regulatory agencies, ensuring clear communication, strategic alignment, and successful outcomes.
- Provide oversight for the review and approval of all product labeling, advertising, and promotional materials to ensure full compliance with regulatory requirements.
Team Leadership & Department Management
- Lead, mentor, and develop a high-performing, multi-disciplinary regulatory affairs team, fostering a culture of accountability, collaboration, and continuous professional growth.
- Establish clear departmental goals, performance metrics, and development plans to ensure the team is equipped to meet the evolving needs of the business.
- Manage the departmental budget, optimize resource allocation, and oversee the selection and management of external consultants and contractors.
- Champion a culture of regulatory intelligence and awareness throughout the entire organization.
Compliance & Post-Market Surveillance
- Partner closely with the Quality Assurance department to ensure the company’s Quality Management System (QMS) is robust and in continuous compliance with 21 CFR 820, ISO 13485, and other applicable standards.
- Oversee all post-market regulatory activities, including the management of adverse event reporting, vigilance systems, product recall strategies, and field safety corrective actions.
- Serve as the lead host for regulatory agency inspections and third-party audits, ensuring meticulous preparation, effective communication, and timely resolution of any findings.
Requirements for the VP, Regulatory Affairs with a Diagnostics Manufacturer – St. Louis, MO
We are seeking an exceptional individual with a deep well of experience and a specific set of qualifications to lead this critical function. The requirements for this role reflect the seniority and strategic importance of the position.
Educational Background
- A Bachelor of Science (B.S.) degree in a relevant scientific field such as Biology, Chemistry, Engineering, or a related discipline is required.
- An advanced degree (M.S., Ph.D., M.D., or J.D.) is strongly preferred and will be a significant differentiator.
- Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) is highly desirable.
Professional Experience
- A minimum of 15 years of progressive experience within the regulatory affairs function of the medical device or in vitro diagnostics (IVD) industry.
- At least 7-10 years of proven experience in a senior leadership capacity (Director, Senior Director, or VP level), with direct responsibility for managing and developing regulatory professionals.
- Extensive, hands-on experience authoring, reviewing, and managing successful submissions for complex diagnostic products, including a strong track record with 510(k)s and PMAs.
- Demonstrated success in leading direct interactions and negotiations with the FDA (CDRH) and major international regulatory bodies.
- Experience in a fast-paced, high-growth environment is essential. Experience with both large, established companies and smaller, entrepreneurial firms is a plus.
Knowledge & Skills
- Expert-level, comprehensive knowledge of U.S. Food and Drug Administration (FDA) regulations, guidances, and policies, particularly 21 CFR Parts 803, 806, 812, and 820.
- Deep and current understanding of international regulatory requirements, including the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746), MDSAP, and requirements in other key markets like China, Japan, and Canada.
- Exceptional strategic thinking and business acumen, with the ability to translate complex regulatory requirements into practical business strategies.
- Superior communication skills (written, verbal, and presentation), with the ability to effectively communicate with technical teams, executive leadership, regulatory authorities, and external partners.
- Unquestionable integrity, ethics, and a strong commitment to compliance and patient safety.
- Proven ability to lead through influence and build strong, collaborative relationships across all levels and functions of an organization.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier executive talent by offering a highly competitive and comprehensive compensation and benefits package. This includes:
Executive Compensation
A highly competitive base salary, a substantial annual performance-based bonus, and a significant long-term incentive package, including stock options or equity grants.
Health & Wellness
Premier medical, dental, and vision insurance plans for you and your dependents, a robust Health Savings Account (HSA) with company contributions, and a comprehensive Employee Assistance Program (EAP) for mental and emotional well-being.
Retirement & Financial Planning
A 401(k) retirement savings plan with a generous company match, along with access to professional financial planning services.
Work-Life Integration
A generous paid time off (PTO) policy, numerous paid company holidays, and a commitment to supporting a healthy work-life balance.
Professional Development
A substantial annual budget for continuous learning, including attendance at key industry conferences, advanced certifications, and executive leadership training.
Relocation
A comprehensive, executive-level relocation package is available for the successful candidate and their family to move to the vibrant St. Louis, MO area.
How to Apply
If you are a visionary and accomplished regulatory affairs leader with the experience and passion to drive the success of a leading-edge diagnostics company, we strongly encourage you to apply for this confidential search. JRG Partners specializes in placing elite talent within the life sciences sector. To be considered, please submit your curriculum vitae and a detailed cover letter outlining your unique qualifications for this role. To learn more about our dedicated expertise in this sector, please visit JRG Partners’ Life Sciences and Healthcare practice area. We look forward to reviewing your application and discussing this exciting opportunity with you.
