Role Overview for Chief Regulatory Officer – Raleigh, NC
JRG Partners is proud to partner exclusively with a pioneering medical device company at the forefront of therapeutic innovation. Located in the vibrant Research Triangle Park (RTP) in Raleigh, NC, our client is dedicated to developing and commercializing next-generation medical technologies that significantly improve patient outcomes. With a robust pipeline and a commitment to quality and safety, they are seeking a visionary and strategic Chief Regulatory Officer (CRO) to join their executive leadership team.
This is a rare opportunity to shape the regulatory landscape of a high-growth, mission-driven organization. The Chief Regulatory Officer will be the principal architect of the company’s global regulatory strategy, providing the expert guidance and leadership necessary to navigate the complex pathways to market approval in the United States, Europe, and other key international regions. Reporting directly to the Chief Executive Officer, the CRO will be a critical voice in the C-suite, ensuring that regulatory excellence is woven into the fabric of the company’s corporate strategy, product development lifecycle, and long-term vision.
The ideal candidate is a seasoned leader with a profound understanding of the medical device industry and a proven track record of securing regulatory approvals for complex, innovative devices. You will be responsible for building and mentoring a world-class regulatory affairs organization, fostering a culture of compliance, and serving as the primary liaison with regulatory bodies worldwide, including the FDA and Notified Bodies. Your strategic insight will be instrumental in balancing business objectives with regulatory requirements, mitigating risks, and accelerating the delivery of life-changing products to patients and clinicians globally. This role demands not only deep technical expertise but also exceptional business acumen, strategic foresight, and the ability to inspire and lead cross-functional teams toward a common goal.
Key Responsibilities of Chief Regulatory Officer – Raleigh, NC
The Chief Regulatory Officer will have a broad and impactful scope of responsibilities, encompassing strategic leadership, tactical execution, and team development. Success in this role requires a hands-on yet strategic approach to the following key areas:
Global Regulatory Strategy Development
Formulate, implement, and maintain a comprehensive and forward-thinking global regulatory strategy that is fully aligned with the company’s commercial and clinical objectives. Provide strategic regulatory counsel to the executive team and Board of Directors on product development, risk assessment, and lifecycle management.
Regulatory Submissions and Approvals
Direct and oversee the entire lifecycle of regulatory submissions. This includes the preparation, review, and filing of Pre-Submissions, Investigational Device Exemptions (IDEs), 510(k) Premarket Notifications, De Novo requests, and Premarket Approvals (PMAs) with the U.S. FDA. Additionally, you will lead efforts for international approvals, including CE Marking under the EU Medical Device Regulation (MDR) and submissions to other competent authorities worldwide.
Health Authority Engagement
Act as the company’s primary and most senior point of contact with all regulatory agencies globally. Proactively build and maintain strong, positive relationships with the FDA, Notified Bodies, and other international health authorities. Lead all negotiations and communications during the review and approval process, as well as during facility inspections and audits.
Regulatory Compliance and Quality Systems Integration
Ensure unwavering compliance with all applicable laws, regulations, and standards. This includes the FDA’s Quality System Regulation (21 CFR 820), ISO 13485, EU MDR, and other relevant global requirements. Collaborate intimately with the Head of Quality Assurance to ensure the Quality Management System (QMS) is robust, effective, and consistently audit-ready.
Post-Market Surveillance and Vigilance
Develop and oversee a comprehensive post-market surveillance program. Ensure timely and accurate reporting of adverse events (Medical Device Reporting – MDRs), manage product complaint handling systems, and lead the regulatory aspects of any potential field actions or recalls.
Team Leadership and Mentorship
Recruit, train, and develop a high-performing regulatory affairs team. Foster a culture of excellence, accountability, and continuous professional growth. Provide mentorship and guidance to team members, ensuring they have the resources and skills needed to succeed.
Cross-Functional Partnership
Serve as a key strategic partner to R&D, Clinical Affairs, Operations, and Marketing/Sales. Provide critical regulatory input at all stages of the product lifecycle, from initial concept and design controls to clinical trial design, labeling development, and promotional material review.
Regulatory Intelligence and Landscape Monitoring
Proactively monitor the evolving global regulatory environment. Analyze new regulations, guidance documents, and industry trends to assess their potential impact on the company. Disseminate this intelligence throughout the organization and adapt strategies accordingly to maintain a competitive edge and ensure continued compliance.
Requirements for the Chief Regulatory Officer – Raleigh, NC
We are seeking an exceptional individual with a distinguished career in medical device regulatory affairs. The successful candidate will possess a unique blend of technical expertise, strategic leadership, and business acumen.
Educational Background
An advanced degree (M.S., Ph.D., or J.D.) in a relevant scientific, engineering, or legal discipline is strongly preferred. A Bachelor’s degree in a related field is required. Regulatory Affairs Certification (RAC) is highly desirable.
Professional Experience
A minimum of 15 years of progressive experience within the medical device regulatory affairs domain. This must include at least 7-10 years in a senior leadership capacity, with demonstrated experience managing and scaling a regulatory affairs department.
Submissions Expertise
A proven, verifiable track record of successfully leading teams to obtain marketing clearance and approval for complex medical devices (Class II and Class III) in major global markets. Extensive hands-on experience with 510(k), PMA, and EU MDR submissions is essential.
Agency Interaction
Substantial first-hand experience serving as the primary correspondent and negotiator with the FDA (CDRH) and EU Notified Bodies. Experience successfully managing pre-submission meetings, advisory panel meetings, and regulatory audits is required.
Technical and Regulatory Knowledge
Deep and comprehensive subject matter expertise in U.S. FDA regulations for medical devices, the European Medical Device Regulation (EU MDR 2017/745), ISO 13485, and other pertinent international standards. Experience with software as a medical device (SaMD), connected devices, or combination products is a significant plus.
Leadership Qualities
Exceptional strategic thinking and problem-solving skills. The ability to translate complex regulatory requirements into actionable business strategies. A demonstrated capacity to lead, influence, and build consensus across all levels of an organization.
Communication Skills
Impeccable written and verbal communication skills. The ability to articulate complex regulatory issues clearly and concisely to diverse audiences, from engineers to board members. Strong negotiation and presentation abilities are a must.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier executive talent. They offer a highly competitive and comprehensive compensation and benefits package, including:
Executive Compensation
A competitive base salary, a significant annual performance-based bonus, and a substantial long-term equity package (stock options/RSUs).
Health and Wellness
Premium medical, dental, and vision insurance plans for you and your dependents. A robust employee wellness program, health savings accounts (HSA), and flexible spending accounts (FSA).
Retirement Planning
A 401(k) plan with a generous company match to help you plan for your future.
Work-Life Balance
A generous paid time off (PTO) policy, paid company holidays, and flexible work arrangements.
Professional Growth
A dedicated budget for professional development, including attendance at major industry conferences, executive coaching, and continuing education.
Relocation
A comprehensive relocation package is available for the ideal candidate and their family to move to the beautiful Raleigh, NC area.
How to Apply
This is an exclusive search being conducted by JRG Partners. To be considered for this career-defining opportunity, please submit your resume and a cover letter detailing your qualifications and strategic leadership experience. We are looking for a leader who is not just a regulatory expert, but a strategic partner who can help drive the future of this innovative company.
JRG Partners is a leader in executive recruitment. To learn more about our expertise in this sector, please visit our medical device and life sciences practice page. We are an equal opportunity employer and value diversity at our company and our clients’. All applications will be treated with the strictest confidence.
