Role Overview for Chief Regulatory Officer – New York, NY
JRG Partners is proud to partner with a trailblazing, venture-backed medical device company at the forefront of diagnostic and therapeutic innovation. Based in the vibrant heart of New York, NY, our client is dedicated to developing groundbreaking technologies that significantly improve patient outcomes and reshape the landscape of modern medicine. They are currently seeking a visionary and highly strategic Chief Regulatory Officer (CRO) to join their executive leadership team. This is a pivotal role for a seasoned professional who will architect and execute a global regulatory strategy that aligns with the company’s ambitious growth and commercialization goals.
The Chief Regulatory Officer will be the ultimate authority on all regulatory matters, providing critical guidance and leadership to navigate the complex and ever-evolving global regulatory environment. This executive will be responsible for ensuring that the company’s products meet all requisite standards for safety and efficacy, securing timely product approvals, and maintaining a state of perpetual compliance.
The ideal candidate will possess a profound understanding of the medical device industry, a proven track record of successful interactions with regulatory bodies like the FDA and EU Notified Bodies, and the ability to lead and inspire a high-performing regulatory affairs team. This position offers a unique opportunity to make a substantial impact on a rapidly growing organization, influencing product development from conception to post-market surveillance and contributing directly to the company’s mission of saving and improving lives.
Key Responsibilities of Chief Regulatory Officer – New York, NY
The Chief Regulatory Officer will assume a wide range of critical responsibilities, steering the company through the intricate pathways of global medical device regulations. Key duties include:
Global Regulatory Strategy Development
Formulate, implement, and maintain a comprehensive and forward-thinking global regulatory strategy for all company products. This includes identifying regulatory pathways for new products, assessing regulatory risks, and developing mitigation strategies for markets including the United States (FDA), European Union (MDR), and other key international regions.
Executive Leadership and Team Management
Build, mentor, and lead a world-class regulatory affairs department. Foster a culture of excellence, collaboration, and continuous improvement. Provide strategic direction, set clear objectives, and manage the department’s budget and resources effectively.
Regulatory Submissions Oversight
Direct and oversee the preparation, submission, and maintenance of all regulatory filings. This includes Investigational Device Exemptions (IDEs), Premarket Approvals (PMAs), 510(k) Premarket Notifications, De Novo requests, CE Mark technical files under EU MDR, and other international registrations. Ensure all submissions are of the highest quality, scientifically sound, and submitted on schedule.
Health Authority Liaison
Serve as the primary point of contact and build strong, credible relationships with regulatory agencies worldwide, including the FDA, Notified Bodies, and other competent authorities. Lead all negotiations and communications related to submissions, inspections, and compliance inquiries.
Compliance and Quality System Integration
Partner closely with the Chief Quality Officer to ensure the company’s Quality Management System (QMS) is robust and compliant with all applicable regulations, including FDA 21 CFR 820 (QSR), ISO 13485, and other global standards. Provide regulatory input for CAPAs, audit findings, and quality system improvements. Ensure all activities are in strict compliance with current FDA regulations for medical devices and other global standards.
Post-Market Surveillance and Vigilance
Establish and oversee comprehensive post-market surveillance programs. Ensure timely and accurate reporting of adverse events, field actions, and recalls (MDRs, Vigilance reports) in accordance with global requirements. Proactively monitor product performance and regulatory landscape changes.
Cross-Functional Collaboration
Act as a key strategic partner to R&D, Clinical Affairs, Operations, and Commercial teams. Provide expert regulatory guidance throughout the entire product lifecycle, from initial concept and design control to labeling, promotional material review, and commercial launch.
Regulatory Intelligence
Continuously monitor, analyze, and interpret the evolving global regulatory landscape. Disseminate critical intelligence to the executive team and relevant departments, ensuring the organization is prepared for future regulatory changes and can leverage new opportunities.
Due Diligence and Business Development Support
Provide regulatory expertise and support for potential mergers, acquisitions, and strategic partnerships. Conduct thorough regulatory due diligence to assess risks and opportunities associated with new technologies or business ventures.
Requirements for the Chief Regulatory Officer – New York, NY
The successful candidate will be a distinguished leader with extensive experience and a deep passion for regulatory affairs in the medical device sector. The specific qualifications we are seeking include:
Educational Background
An advanced degree (M.S., Ph.D., M.D., or J.D.) in a scientific, engineering, or legal discipline is strongly preferred. A Bachelor’s degree in a relevant field is required. Regulatory Affairs Certification (RAC) is highly desirable.
Professional Experience
A minimum of 15 years of progressive experience in medical device regulatory affairs, with at least 7 years in a senior leadership capacity (Director, VP, or higher).
Device Expertise
Extensive, hands-on experience with a variety of medical devices, including complex Class II and Class III devices. Experience with software as a medical device (SaMD), combination products, or diagnostic devices is a significant plus.
Global Regulatory Acumen
Demonstrated mastery of global medical device regulations, including deep expertise in US FDA regulations (PMA, 510(k), De Novo, IDE), the European Medical Device Regulation (EU MDR 2017/745), and regulations in other key markets such as Canada, Japan, and China.
Proven Track Record
A history of successful regulatory submissions and product approvals in major global markets. Verifiable experience leading successful interactions and negotiations with the FDA and Notified Bodies.
Leadership Skills
Exceptional leadership and team-building skills with the ability to inspire, motivate, and develop a high-performing team. Proven ability to operate effectively at both strategic and tactical levels.
Communication and Interpersonal Skills
Superior written and verbal communication skills. The ability to articulate complex regulatory concepts to diverse audiences, from engineers to board members. Excellent negotiation, influencing, and problem-solving abilities.
Strategic Mindset
Strong business acumen and the ability to think strategically, translating regulatory requirements into actionable business plans and competitive advantages.
Personal Attributes
Unquestionable integrity, ethics, and professionalism. A proactive, results-oriented leader who thrives in a fast-paced, innovative environment. Must be detail-oriented, with strong organizational and project management skills.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier talent by offering a highly competitive and comprehensive compensation and benefits package. This includes:
Executive Compensation
A highly competitive base salary commensurate with experience.
Performance Bonus
A significant annual performance-based bonus tied to individual and company achievements.
Equity Participation
A substantial equity stake (stock options or RSUs) in the company, providing a meaningful opportunity for long-term wealth creation.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your dependents with low employee contributions.
Retirement Savings
A 401(k) plan with a generous company matching contribution.
Generous Paid Time Off
A flexible and generous paid time off (PTO) policy, including vacation, sick days, and company holidays.
Professional Development
A dedicated budget for continuous learning, including conferences, certifications, and executive coaching.
Relocation Assistance
A comprehensive relocation package is available for exceptional candidates.
Work-Life Balance
A supportive and collaborative work environment that values the well-being of its employees.
How to Apply
JRG Partners has been exclusively retained for this critical executive search. To be considered for this exceptional opportunity, please submit your resume and a cover letter detailing your qualifications and strategic regulatory accomplishments. We are seeking a leader who can not only ensure compliance but also leverage regulatory strategy as a key driver of business success.
For more information about our expertise in this sector and to explore this and other opportunities, we invite you to connect with our team. JRG Partners is a leader in medical device executive search, and we look forward to reviewing your application. All inquiries and applications will be handled with the strictest confidence.
