Role Overview for Chief Regulatory Officer – Boston, MA
JRG Partners is proud to partner with a pioneering, research-driven medical device company based in the vibrant life sciences hub of Boston, MA. Our client is at the forefront of developing transformative technologies that address critical unmet medical needs and significantly improve patient outcomes. They are seeking a visionary and strategic Chief Regulatory Officer (CRO) to join their executive leadership team. This is a paramount role responsible for architecting and executing the company’s global regulatory strategy, ensuring seamless navigation of the complex international regulatory landscape.
The successful candidate will be a seasoned leader with an impeccable track record in the medical device industry, particularly with Class II and Class III devices. As the CRO, you will be the ultimate authority on regulatory matters, providing critical guidance to the CEO, board of directors, and cross-functional teams. You will be instrumental in shaping the company’s product development lifecycle, from early-stage concept through to commercialization and post-market surveillance. Your leadership will directly impact the company’s ability to achieve its strategic objectives, accelerate growth, and maintain its reputation for quality and compliance.
This position requires a dynamic individual who can balance strategic, forward-thinking planning with hands-on execution, fostering a culture of regulatory excellence and integrity throughout the organization. You will be the primary liaison with global health authorities, including the FDA, Notified Bodies, and other international agencies, building and maintaining relationships based on trust and transparency. This is a unique opportunity to make a lasting impact on a rapidly growing organization dedicated to changing the future of healthcare.
Key Responsibilities of Chief Regulatory Officer – Boston, MA
The Chief Regulatory Officer will have a broad and impactful scope of responsibilities, overseeing all aspects of the regulatory affairs function. This includes setting the strategic direction, managing global submissions, ensuring ongoing compliance, and leading a high-performing team.
Global Regulatory Strategy
Develop, articulate, and implement comprehensive global regulatory strategies for the company’s entire product portfolio, including novel and existing medical devices. Ensure regulatory strategies are aligned with business objectives, product development timelines, and commercialization goals. Proactively identify and assess regulatory risks and opportunities in key markets worldwide.
Regulatory Submissions and Approvals
Direct and oversee the preparation, submission, and maintenance of all regulatory applications and registrations. This includes, but is not limited to, Premarket Approvals (PMAs), 510(k) Premarket Notifications, Investigational Device Exemptions (IDEs), De Novo requests, CE Markings under MDR, and other international dossiers. Ensure all submissions are of the highest quality, scientifically sound, and submitted on schedule.
Health Authority Interactions
Serve as the primary point of contact and lead negotiator with global regulatory agencies, including the FDA, European Notified Bodies, and other international health authorities. Foster positive and productive relationships with regulators. Plan and lead key meetings, such as pre-submission meetings and advisory panel preparations.
Compliance and Quality Systems Leadership
Provide executive oversight of the regulatory compliance framework. Collaborate closely with the Head of Quality to ensure the Quality Management System (QMS) is robust, effective, and compliant with all applicable regulations and standards, such as FDA 21 CFR 820 (QSR), ISO 13485, and the EU Medical Device Regulation (MDR). Oversee regulatory audits and inspections, ensuring successful outcomes.
Post-Market Surveillance and Vigilance
Oversee all post-market regulatory activities, including the development and implementation of post-market surveillance plans, adverse event reporting (MDRs, Vigilance reports), recall management, and product lifecycle management from a regulatory perspective.
Team Leadership and Development
Build, mentor, and lead a world-class global regulatory affairs team. Foster a culture of excellence, collaboration, and continuous learning. Establish clear objectives, provide ongoing coaching, and manage resource allocation to ensure departmental goals are met efficiently and effectively.
Cross-Functional Collaboration
Act as a key strategic partner to R&D, Clinical Affairs, Quality, Operations, and Commercial teams. Provide expert regulatory input and guidance throughout the product lifecycle, from initial concept and design controls to clinical trial design, labeling, promotional material review, and commercial launch.
Regulatory Intelligence
Monitor, interpret, and communicate changes in the global regulatory environment. Analyze the potential impact of new regulations, guidances, and standards on the company’s products and strategies, and develop proactive plans to adapt and comply. Ensure the organization has a deep and functional understanding of current FDA regulations for medical devices and other relevant international laws.
Requirements for the Chief Regulatory Officer – Boston, MA
We are seeking a distinguished professional with extensive experience and a proven ability to lead in a complex, regulated environment. The ideal candidate will possess a unique blend of scientific knowledge, regulatory acumen, and executive leadership skills.
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 15-20 years of progressive experience in medical device regulatory affairs, with at least 10 years in a senior leadership role (Director, VP, or higher).
Device Expertise
Extensive, hands-on experience with high-risk devices, specifically Class III (PMA) and complex Class II (510(k)) products. Experience with software as a medical device (SaMD), combination products, or implantable devices is highly advantageous.
Global Regulatory Knowledge
Demonstrated mastery of global medical device regulations, including deep expertise in US FDA regulations (QSR, IDE, PMA, 510(k)), the European Medical Device Regulation (EU MDR 2017/745), and regulations in other key international markets (e.g., Canada, Japan, China, Australia).
Proven Leadership
A documented track record of successfully building, leading, and developing high-performing, multi-site regulatory affairs teams. Experience managing significant departmental budgets and resources.
Strategic Thinker
Ability to think strategically and translate complex regulatory requirements into actionable business strategies. Experience providing regulatory counsel at the executive and board levels.
Communication Skills
Exceptional written and verbal communication skills. The ability to articulate complex regulatory concepts clearly and persuasively to diverse audiences, from engineers to investors to regulatory authorities.
Negotiation and Influence
Superior negotiation skills and a proven ability to influence outcomes with regulatory agencies, internal stakeholders, and external partners.
Problem-Solving Acumen
Strong analytical and problem-solving skills with a demonstrated ability to navigate ambiguity and make sound judgments under pressure.
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 reflects the critical importance of the Chief Regulatory Officer role to the organization’s success.
Executive Compensation
A highly competitive base salary commensurate with experience and market standards.
Incentive Programs
A lucrative annual performance-based bonus plan and a significant long-term incentive package, including substantial equity (stock options or RSUs), to ensure alignment with the company’s long-term success.
Comprehensive Health & Wellness
Premium medical, dental, and vision insurance plans for you and your dependents. A robust wellness program, including gym memberships, mental health resources, and employee assistance programs (EAP).
Retirement Savings
A 401(k) retirement plan with a generous company match to help you plan for your future.
Paid Time Off
A generous paid time off (PTO) policy, including vacation, sick leave, and company-paid holidays, to support a healthy work-life balance.
Relocation Assistance
A comprehensive relocation package is available for exceptional candidates moving to the Boston area.
Professional Development
A substantial budget for continuous learning, including attendance at major industry conferences, executive coaching, and leadership development programs.
Work Environment
A dynamic, innovative, and collaborative work culture located in a state-of-the-art facility in the heart of Boston’s life sciences ecosystem.
How to Apply
JRG Partners is exclusively managing the search for this pivotal Chief Regulatory Officer position. If you are a visionary regulatory leader with the experience and passion to drive a leading medical device company to new heights, we encourage you to apply.
To be considered for this confidential opportunity, please submit your resume and a cover letter detailing your qualifications and strategic accomplishments. For more information on our expertise in this sector, please visit our Medical Device & Life Sciences practice area page. We look forward to connecting with you to discuss this exciting role in more detail.
