Role Overview for VP, Regulatory Affairs with a MedTech Company – St. Louis, MO
JRG Partners is proud to represent a pioneering medical technology company based in St. Louis, MO, in their search for a visionary and strategic Vice President of Regulatory Affairs. Our client is at the forefront of developing life-changing medical devices that address critical unmet needs in healthcare. With a culture rooted in innovation, scientific rigor, and patient-centricity, they are poised for significant global expansion. This is a rare opportunity to join a dynamic executive leadership team and shape the regulatory landscape for a portfolio of groundbreaking products.
As the Vice President of Regulatory Affairs, you will be the principal architect of the company’s global regulatory strategy. This executive role is not just about compliance; it’s about providing strategic leadership that enables innovation and accelerates market access. You will be responsible for building and leading a world-class regulatory affairs department, ensuring that all products meet and exceed the stringent requirements of health authorities worldwide, including the FDA, EU Notified Bodies, and other international agencies. Your expertise will be critical in navigating the complex and evolving regulatory environment, from initial product conception through to post-market surveillance. You will serve as the company’s primary voice to regulatory bodies, building relationships based on trust, transparency, and scientific integrity.
This position demands a leader who can balance strategic foresight with meticulous execution, fostering a culture of regulatory excellence and collaboration across the entire organization. You will be a key advisor to the CEO and the Board of Directors, providing critical insights that will influence business decisions, product development pipelines, and international market entry strategies. Your leadership will directly impact the company’s ability to deliver its innovative technologies to patients and clinicians around the globe, solidifying its position as a leader in the MedTech industry.
Key Responsibilities of VP, Regulatory Affairs with a MedTech Company – St. Louis, MO
Global Regulatory Strategy
Develop, implement, and lead comprehensive global regulatory strategies for the company’s entire product portfolio, including Class II and Class III medical devices. Ensure strategies are aligned with business objectives, competitive landscape, and timelines for market entry in key regions such as the US, EU, Canada, and Asia-Pacific.
Pre-Market Submissions
Provide executive oversight for the preparation, submission, and maintenance of all regulatory applications. This includes, but is not limited to, Investigational Device Exemptions (IDEs), Premarket Notifications (510(k)s), Premarket Approvals (PMAs), De Novo requests, and international dossiers (e.g., EU MDR Technical Files). Ensure all submissions are of the highest quality to facilitate efficient review and approval.
Health Authority Liaison
Act as the primary correspondent and strategic liaison with global regulatory agencies, including the U.S. Food and Drug Administration (FDA), Notified Bodies, and other international health authorities. Lead and manage all negotiations and communications, fostering positive and productive relationships.
Team Leadership & Development
Recruit, lead, mentor, and develop a high-performing team of regulatory affairs professionals. Foster a culture of excellence, collaboration, accountability, and continuous learning. Manage departmental resources, including budget planning and allocation, to ensure team effectiveness and efficiency.
Regulatory Compliance & Intelligence
Ensure steadfast compliance with all applicable regulations, standards, and guidance documents, including FDA regulations (e.g., 21 CFR 820), EU MDR/IVDR, ISO 13485, and other relevant international requirements. Proactively monitor the global regulatory landscape, interpret changes, and assess their impact on the business, implementing necessary adjustments to strategies and processes.
Cross-Functional Collaboration
Serve as a key strategic partner to R&D, Clinical Affairs, Quality Assurance, Operations, and Commercial teams. Provide expert regulatory guidance throughout the entire product lifecycle, from concept and design controls to clinical trials, manufacturing, and commercialization.
Post-Market Surveillance
Oversee all post-market regulatory activities, including the management of adverse event reporting, vigilance systems, complaint handling, product recalls, and field safety corrective actions. Ensure robust systems are in place for post-market data collection and analysis.
Quality Management System (QMS) Integration
Collaborate closely with the Head of Quality to ensure the company’s QMS is fully compliant with regulatory requirements and effectively supports the business. Participate in management reviews and provide regulatory input for continuous improvement of the QMS.
Business Development Support
Provide regulatory due diligence and strategic input for potential mergers, acquisitions, licensing agreements, and other business development opportunities to assess risks and opportunities from a regulatory perspective.
Requirements for the VP, Regulatory Affairs with a MedTech Company – St. Louis, MO
Educational Background
A minimum of a Bachelor’s degree in a relevant scientific, engineering, or life sciences discipline is required. An advanced degree (MS, PhD, MD, or JD) is strongly preferred.
Professional Experience
A minimum of 15 years of progressive experience in regulatory affairs within the medical device industry, with at least 7-10 years in a significant leadership capacity managing teams and strategy.
Device Expertise
Extensive experience with a range of medical devices, including complex Class II and Class III devices, is essential. Experience with software as a medical device (SaMD), implantable devices, or capital equipment is highly advantageous.
Submission Track Record
A proven and demonstrable track record of successfully authoring, submitting, and gaining approval for a variety of regulatory submissions, including 510(k)s and PMAs in the US and Technical Files/Design Dossiers in the EU.
Global Regulatory Knowledge
Deep and current expertise in global medical device regulations, standards, and guidances, including US FDA regulations, the European Medical Device Regulation (MDR), Health Canada regulations, and requirements in other key international markets.
Leadership & Influence
Exceptional leadership skills with the proven ability to build, inspire, and manage high-caliber teams. Must possess executive presence and the ability to effectively influence and negotiate with internal stakeholders and external regulatory bodies.
Strategic Acumen
Strong strategic thinking skills, with the ability to analyze complex situations, devise innovative regulatory pathways, and align regulatory strategy with overarching business goals.
Communication Skills
Impeccable written and verbal communication skills. The ability to distill complex regulatory information into clear, concise, and actionable insights for diverse audiences, from engineers to the Board of Directors.
Certifications
Regulatory Affairs Certification (RAC) is highly desired.
Location
The ability and willingness to be based at the company’s headquarters in St. Louis, MO, is required.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier executive talent and offers a comprehensive and competitive compensation package, including:
Executive Compensation
A highly competitive base salary, significant annual performance-based bonus, and a meaningful long-term incentive package (equity/stock options).
Comprehensive Health & Wellness
Premium medical, 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.
Paid Time Off
A generous and flexible paid time off (PTO) policy, in addition to paid company holidays.
Professional Growth
A substantial budget for professional development, including attendance at major industry conferences, executive training programs, and support for certifications.
Relocation Support
A comprehensive relocation package is available for the successful candidate and their family.
Work Environment
An opportunity to work within a mission-driven, innovative, and collaborative culture with a passionate team dedicated to improving patient outcomes.
How to Apply
This is a retained search conducted exclusively by JRG Partners. If you are a transformative regulatory leader with the experience and passion to drive a leading MedTech company’s success, we invite you to apply. To be considered for this confidential opportunity, please submit your resume and a cover letter detailing your qualifications. JRG Partners is a leader in executive recruitment, and you can explore our expertise in the Life Sciences executive search space to learn more about our commitment to connecting exceptional talent with industry-defining companies. We look forward to reviewing your application.
