Role Overview for Chief Regulatory Officer – Cambridge, MA
Are you a visionary regulatory leader with a passion for bringing life-changing medical technologies to patients worldwide? JRG Partners is exclusively representing a pioneering medical device company based in the heart of Cambridge, MA’s vibrant innovation ecosystem. We are seeking a strategic and results-driven Chief Regulatory Officer (CRO) to join their executive leadership team. This is a rare opportunity to shape the regulatory destiny of a rapidly growing organization at the forefront of medical technology.
As the Chief Regulatory Officer, you will be the principal architect of the company’s global regulatory strategy. Reporting directly to the Chief Executive Officer, you will provide the critical guidance and executive leadership necessary to navigate the complex and evolving global regulatory landscape. Your expertise will be instrumental in ensuring compliant, timely, and successful product approvals, enabling the company to achieve its ambitious commercial goals.
You will serve as the primary interface with regulatory bodies such as the FDA and international health authorities, building relationships founded on trust and transparency. This role demands a unique blend of deep technical knowledge, strategic foresight, business acumen, and inspirational leadership. You will be responsible for building and mentoring a world-class regulatory affairs organization capable of supporting a diverse and innovative product pipeline. If you are ready to make a significant impact on both a company’s trajectory and the future of patient care, we invite you to apply for this pivotal role.
Key Responsibilities of Chief Regulatory Officer – Cambridge, MA
The Chief Regulatory Officer will have a broad and impactful scope of responsibilities, encompassing strategic planning, execution, and team leadership. Success in this role will be defined by the ability to seamlessly integrate regulatory excellence into the fabric of the business.
Global Regulatory Strategy Development
Architect and implement comprehensive, forward-thinking global regulatory strategies for a diverse portfolio of Class II and Class III medical devices. This includes mapping out regulatory pathways from concept through commercialization, considering the nuances of key markets including the US, EU, Japan, and China.
Executive Leadership & Counsel
Serve as a key member of the executive team, providing expert regulatory counsel on strategic business decisions, including product development, clinical trial design, M&A due diligence, and international expansion.
Regulatory Agency Liaison
Act as the principal point of contact and build strong, collaborative relationships with regulatory agencies worldwide, including the FDA’s Center for Devices and Radiological Health (CDRH), Notified Bodies in Europe, and other international health authorities. Masterfully navigate complex negotiations and communications to ensure timely and favorable review outcomes.
Submission Oversight & Management
Provide executive oversight for the preparation, submission, and maintenance of all regulatory filings. This includes, but is not limited to, Investigational Device Exemptions (IDEs), Premarket Notifications (510(k)s), Premarket Approvals (PMAs), De Novo requests, and CE Mark technical files under the EU MDR.
Compliance & Quality Systems Integration
Partner closely with the Head of Quality to ensure the company’s Quality Management System (QMS) is robust, scalable, and in full compliance with global standards such as 21 CFR 820 (QSR), ISO 13485, and the EU Medical Device Regulation (MDR).
Post-Market Surveillance & Vigilance
Oversee all post-market activities, including the development and execution of surveillance plans, management of adverse event reporting, vigilance systems, and coordination of any necessary product recalls or field actions.
Cross-Functional Collaboration
Foster a culture of regulatory awareness and partnership across the organization. Provide critical regulatory input to R&D, Clinical, Operations, and Commercial teams to ensure regulatory requirements are integrated throughout the entire product lifecycle.
Team Leadership & Development
Recruit, train, and mentor a high-performing regulatory affairs team. Cultivate a culture of excellence, accountability, and continuous learning, ensuring the team has the skills and resources to meet current and future business needs.
Regulatory Intelligence
Proactively monitor the global regulatory environment for changes in regulations, standards, and guidance documents. Analyze the potential impact on the business and develop proactive strategies to adapt and maintain compliance.
Requirements for the Chief Regulatory Officer – Cambridge, MA
The ideal candidate will be a seasoned regulatory affairs executive with a proven track record of success within the medical device industry. We are looking for a leader who combines deep regulatory expertise with strategic thinking and exceptional leadership capabilities.
Educational Background
An advanced degree (M.S., Ph.D., or J.D.) in a relevant scientific, engineering, or legal field is strongly preferred. A Bachelor’s degree in a technical discipline is required.
Professional Experience
A minimum of 15-20 years of progressive experience within the medical device regulatory affairs domain, with at least 10 years in a senior leadership capacity (Director, VP, or higher). Your career must demonstrate a clear trajectory of increasing responsibility and strategic impact.
Device Expertise
Extensive, hands-on experience with complex, high-risk medical devices (Class III, active implantables, or novel Class II technologies) is essential. A proven track record of successfully guiding such products through the PMA or De Novo pathways is required.
Global Regulatory Acumen
Deep, practical knowledge of US FDA regulations (e.g., 21 CFR Parts 803, 806, 812, 814, 820) and international regulations, with a particular emphasis on the EU MDR. Experience with submissions in other key markets (e.g., Japan, China, Canada) is highly desirable.
Leadership & Management Skills
Demonstrated ability to build, lead, and inspire high-performing teams. Experience managing departmental budgets, resources, and strategic planning is essential. Must possess executive presence and the ability to influence at all levels of the organization.
Communication & Interpersonal Skills
Exceptional written and verbal communication skills. The ability to articulate complex regulatory concepts to diverse audiences, from engineers to board members, is critical. Proven ability to negotiate effectively with regulatory authorities.
Strategic & Business Acumen
Ability to think strategically and translate regulatory requirements into actionable business plans. Experience providing regulatory input on corporate strategy and business development activities is a significant plus.
Certifications
Regulatory Affairs Certification (RAC) is highly preferred.
Benefits & Perks Offered
Our client offers a highly competitive and comprehensive compensation and benefits package designed to attract and retain top-tier executive talent. This includes:
Executive Compensation
A competitive base salary complemented by a significant annual performance-based bonus.
Equity Participation
A substantial equity grant (stock options or RSUs) to ensure you share in the long-term success of the company.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your eligible dependents.
Retirement Savings
A 401(k) plan with a generous company matching contribution.
Paid Time Off
A flexible and generous paid time off (PTO) policy, in addition to company-paid holidays.
Professional Development
A dedicated budget for continuous learning, including conferences, certifications, and executive coaching.
Relocation Assistance
A comprehensive relocation package is available for the right candidate.
Work Environment
A dynamic, innovative, and collaborative culture located in the world’s leading biotech and medtech hub.
How to Apply
JRG Partners is proud to partner with this industry leader to find their next Chief Regulatory Officer. We are committed to connecting exceptional talent with transformative opportunities. To learn more about our expertise in this sector and view other executive-level positions, please visit our Life Sciences practice area page.
If you are a qualified candidate who meets the requirements outlined above and is ready to take on this challenging and rewarding leadership role, we encourage you to apply. Please submit your confidential resume and a cover letter detailing your relevant experience for immediate consideration. We look forward to reviewing your application.
