Role Overview for EVP, Global Regulatory Affairs with a Diagnostics Company – St. Louis, MO
JRG Partners is proud to partner with a pioneering, publicly-traded global diagnostics company in the search for an exceptional Executive Vice President (EVP) of Global Regulatory Affairs. Based at their corporate headquarters in St. Louis, MO, this is a career-defining opportunity to join a dynamic executive leadership team and shape the future of diagnostic medicine worldwide. Our client is at the forefront of developing innovative solutions that empower clinicians and improve patient outcomes, and this role is absolutely critical to their continued growth and success.
As the EVP of Global Regulatory Affairs, you will serve as the chief architect and steward of the company’s global regulatory strategy. This is not merely a compliance function; it is a strategic business partnership that is integral to every stage of the product lifecycle, from initial concept through to post-market surveillance. You will be responsible for providing the vision, leadership, and hands-on guidance to a talented global team, ensuring that our client’s groundbreaking diagnostic products navigate the complex and ever-evolving international regulatory landscape with precision and speed. You will be the company’s primary voice and lead negotiator with health authorities across the globe, including the U.S. Food and Drug Administration (FDA), European Notified Bodies, and other key international agencies. Your expertise will directly influence product development timelines, market access strategies, and the company’s overall competitive advantage. This role requires a leader with exceptional executive presence, deep technical and regulatory acumen, and a proven ability to build and inspire high-performing teams in a fast-paced, innovative environment.
The ideal candidate is a seasoned veteran of the medical device or in-vitro diagnostics (IVD) industry, possessing a profound understanding of the intricate regulatory pathways in major global markets. You are a strategic thinker who can balance business objectives with uncompromising compliance, and you have a track record of securing timely approvals for complex products. Reporting directly to the Chief Executive Officer, you will be a trusted advisor to the C-suite and the Board of Directors on all regulatory matters, providing critical insights that inform long-range planning, risk management, and corporate strategy. If you are a transformative leader passionate about bringing life-changing diagnostic technologies to patients around the world, we invite you to explore this unparalleled opportunity.
Key Responsibilities of EVP, Global Regulatory Affairs with a Diagnostics Company – St. Louis, MO
Executive & Strategic Leadership
Develop, articulate, and execute a comprehensive and forward-thinking global regulatory strategy that aligns with the company’s corporate objectives and product pipeline. Serve as a key member of the executive leadership team, providing expert counsel on regulatory risks, opportunities, and the potential impact of emerging global regulations and trends. Proactively shape the regulatory environment by participating in industry trade associations and policy discussions.
Global Regulatory Submissions & Approvals
Direct and oversee the entire lifecycle of regulatory submissions for all products worldwide. This includes the strategic planning, preparation, submission, and maintenance of U.S. filings (e.g., 510(k)s, De Novo requests, Investigational Device Exemptions (IDEs), and Premarket Approval (PMA) applications) and international dossiers (e.g., EU CE-marking under IVDR, Health Canada licenses, submissions in APAC and LATAM regions). Ensure all submissions are of the highest quality to facilitate efficient review and timely approvals.
Team Development & Mentorship
Lead, mentor, and develop a world-class global regulatory affairs organization. Foster a culture of excellence, accountability, collaboration, and continuous improvement. Attract, retain, and develop top talent, ensuring the team has the skills, resources, and motivation to meet current and future business needs. Structure the department for optimal efficiency and global alignment.
Health Authority Engagement
Act as the company’s primary senior representative in all interactions with global regulatory agencies. Cultivate and maintain strong, positive relationships with officials at the FDA, Notified Bodies, and other international health authorities. Lead and prepare teams for critical agency meetings, negotiations, and regulatory inspections, ensuring professional and effective communication.
Regulatory Compliance & Quality Systems Integration
Ensure the company maintains a state of robust and continuous compliance with all applicable global regulations, standards, and guidance documents. Partner closely with the EVP of Quality Assurance to ensure the Quality Management System (QMS) is fully compliant and effectively supports regulatory requirements. Oversee regulatory audits and inspections, and manage the timely resolution of any findings.
Cross-Functional Collaboration
Champion a “regulatory-first” mindset across the organization. Collaborate seamlessly with R&D, Clinical Affairs, Operations, and Commercial teams to provide regulatory input and guidance from the earliest stages of product development through to commercialization and post-market activities. Ensure that regulatory requirements are integrated into product design, labeling, and promotional materials.
Post-Market Surveillance & Vigilance
Oversee the global post-market regulatory function, including the management of adverse event reporting, vigilance systems, product recalls, and field safety corrective actions. Ensure all post-market obligations are met in a timely and compliant manner across all jurisdictions.
Regulatory Intelligence & Policy
Establish and maintain a robust regulatory intelligence process to monitor, interpret, and communicate the impact of new or changing regulations, standards, and guidance documents on the business. Translate intelligence into actionable strategies to ensure proactive adaptation and continued compliance.
Budget & Resource Management
Develop and manage the annual budget for the Global Regulatory Affairs department, ensuring efficient allocation of financial and human resources to achieve strategic goals. Justify resource needs and manage external consultants and contractors effectively.
Due Diligence & Business Development Support
Provide critical regulatory expertise and leadership for due diligence activities related to potential mergers, acquisitions, licensing deals, and strategic partnerships. Assess the regulatory risks and opportunities of potential target assets and companies.
Requirements for the EVP, Global Regulatory Affairs with a Diagnostics Company – St. Louis, MO
Educational Background
An advanced degree (M.S., Ph.D., M.D., or Pharm.D.) in a life science, engineering, or related field is strongly preferred. A Bachelor’s degree in a relevant scientific discipline is required. Regulatory Affairs Certification (RAC) is a significant plus.
Executive Experience
A minimum of 20 years of progressive experience in regulatory affairs within the in-vitro diagnostics (IVD) or medical device industry. At least 10 of these years must be in a senior leadership capacity (Director, VP, or higher) with a proven track record of managing global teams and strategy.
Extensive FDA Expertise
Demonstrated, hands-on experience in leading successful submissions and interactions with the FDA. Deep expertise with a variety of submission types, including 510(k), De Novo, IDE, and complex PMA applications for high-risk devices is essential.
Global Regulatory Mastery
Proven experience securing product approvals and managing compliance in key international markets. In-depth, practical knowledge of European regulations, specifically the In Vitro Diagnostic Regulation (IVDR), is mandatory. Experience with Health Canada, Japan’s PMDA, China’s NMPA, and other major global markets is highly desirable.
Strategic Leadership & Business Acumen
Must be a strategic thinker with the ability to translate regulatory requirements into actionable business strategies. Proven experience as a member of a senior leadership team, contributing to broader corporate strategy. Strong financial acumen and experience with budget management are required.
Exceptional Communication Skills
Impeccable written and verbal communication skills, with the ability to effectively present complex regulatory information to diverse audiences, from engineers to the Board of Directors and regulatory authorities. Proven negotiation and influencing skills are critical.
Proven Team Builder
Demonstrated success in recruiting, developing, and leading high-performing, multi-site global regulatory affairs teams. A history of fostering a positive, collaborative, and results-oriented team culture.
Technical Proficiency
A strong scientific and technical understanding of IVD product development, including areas such as molecular diagnostics, immunoassays, or clinical chemistry. Ability to engage in technical discussions with R&D and clinical teams.
Location & Travel
The ability to be based in the St. Louis, MO metropolitan area is required. The role will involve domestic and international travel (estimated at 20-30%) to engage with global teams and health authorities.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier executive talent and offers a highly competitive and comprehensive compensation and benefits package, including:
Executive Compensation
A highly competitive base salary, a significant annual performance-based bonus, and a substantial long-term equity incentive package (stock options and/or RSUs).
Health & Wellness
Premium, comprehensive health, dental, and vision insurance plans for you and your dependents. A robust wellness program, including gym membership reimbursement and mental health resources.
Retirement Savings
A 401(k) retirement plan with a generous company matching contribution. Access to financial planning services.
Paid Time Off
A generous and flexible paid time off (PTO) policy, in addition to company-paid holidays.
Relocation Assistance
A comprehensive, executive-level relocation package is available for the successful candidate and their family.
Professional Development
A dedicated budget for continuous learning, including attendance at key industry conferences, executive coaching, and leadership development programs.
Additional Benefits
Company-paid life insurance, short-term and long-term disability insurance, and an Employee Assistance Program (EAP).
How to Apply
This is an exclusive, retained search conducted by JRG Partners. If you are a visionary regulatory leader with the experience and drive to make a significant impact on a global scale, we encourage you to apply. To be considered for this confidential opportunity, please submit your resume and a cover letter outlining your qualifications.
JRG Partners is a leader in executive recruitment, and we specialize in placing top talent within the life sciences and healthcare sectors. To learn more about our expertise and explore other opportunities, please visit the JRG Partners’ Life Sciences & Healthcare Executive Search practice page.
Our client is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
