Role Overview for Chief Regulatory Officer – Philadelphia, PA
JRG Partners is proud to announce an exclusive search for a visionary and strategic Chief Regulatory Officer (CRO) on behalf of our client, a pioneering medical device company based in the vibrant life sciences hub of Philadelphia, PA. This is a paramount executive leadership position for an individual poised to make a significant impact on global health by guiding innovative medical technologies through complex regulatory landscapes.
The successful candidate will be the cornerstone of the executive team, responsible for developing, implementing, and directing the company’s global regulatory strategy. This role extends far beyond mere compliance; it demands a forward-thinking leader who can anticipate regulatory trends, forge strong relationships with international agencies, and seamlessly integrate regulatory intelligence into the core business strategy, ensuring that life-saving products reach patients safely and efficiently.
As the Chief Regulatory Officer, you will hold ultimate responsibility for the company’s relationship with regulatory bodies worldwide, including the FDA, EU Notified Bodies, and other competent authorities. You will be instrumental in shaping the company’s long-term vision, providing critical guidance on product development pipelines, clinical trial design, and market access strategies. Your expertise will be the critical factor in navigating the evolving challenges of the medical device industry, from the complexities of the EU Medical Device Regulation (MDR) to the dynamic requirements of emerging markets.
This position requires a unique blend of scientific acumen, legal expertise, business savvy, and inspirational leadership. You will be tasked with building and mentoring a world-class regulatory affairs organization, fostering a culture of quality, integrity, and proactive compliance that permeates every level of the company. This is a career-defining opportunity to join a fast-growing, mission-driven organization and lead the regulatory function at the highest strategic level.
Key Responsibilities of Chief Regulatory Officer – Philadelphia, PA
The Chief Regulatory Officer will direct a comprehensive range of regulatory activities, ensuring alignment with the company’s strategic objectives. Key responsibilities include:
Strategic Leadership & Global Vision
- Develop, articulate, and execute a robust global regulatory strategy that supports the company’s product pipeline and commercial goals.
- Serve as a key member of the executive leadership team, providing expert counsel on regulatory matters, risk assessment, and strategic planning.
- Monitor the global regulatory environment for changes and trends, proactively advising the company on potential impacts and necessary strategic adjustments.
- Act as the primary liaison and company spokesperson with all global regulatory agencies, fostering transparent, professional, and effective relationships.
- Provide regulatory due diligence and strategic input for potential mergers, acquisitions, and partnership opportunities.
Regulatory Submissions & Approvals
- Oversee the preparation, submission, and maintenance of all regulatory applications, including Premarket Approvals (PMAs), 510(k)s, Investigational Device Exemptions (IDEs), CE Mark Technical Files/Design Dossiers, and other international registrations.
- Lead negotiations with regulatory authorities to ensure timely and favorable review outcomes for product submissions.
- Direct the development of regulatory strategies for novel and complex devices, ensuring the most efficient pathway to market is identified and pursued.
- Ensure that all product labeling, promotional materials, and advertising content comply with applicable regulations worldwide.
Compliance & Post-Market Surveillance
- Ensure company-wide compliance with all applicable regulations and standards, including FDA’s Quality System Regulation (QSR), ISO 13485, EU MDR/IVDR, and other country-specific requirements.
- Lead the company’s response to regulatory agency inspections, audits, and inquiries, ensuring professional and timely resolution.
- Oversee the entire post-market surveillance and vigilance system, including the management of adverse event reporting, recalls, and field safety corrective actions.
- Collaborate with the Quality Assurance department to maintain a state-of-the-art Quality Management System (QMS) that is both compliant and efficient.
Team Development & Mentorship
- Lead, mentor, and develop a high-performing global regulatory affairs team, fostering a culture of excellence, collaboration, and continuous learning.
- Establish clear objectives, provide regular feedback, and manage the professional development of all team members.
- Manage the departmental budget, resource allocation, and organizational structure to effectively support the company’s growing needs.
Requirements for the Chief Regulatory Officer – Philadelphia, PA
We are seeking a seasoned and accomplished leader with a proven track record of success in the medical device industry.
Required Qualifications
- An advanced degree (M.S., Ph.D., M.D., or J.D.) in a scientific, medical, or legal discipline is required.
- A minimum of 15 years of progressive experience within the medical device regulatory affairs field, with at least 8-10 years in a senior leadership capacity (Director, VP, or higher).
- Demonstrable track record of successful pre-market submissions and approvals for complex, high-risk medical devices (Class IIb/III) in the US and EU.
- Expert-level knowledge of global medical device regulations, including in-depth familiarity with U.S. Food and Drug Administration (FDA) regulations (21 CFR 820, 812, 814, etc.), the European Medical Device Regulation (EU MDR 2017/745), and standards such as ISO 13485.
- Significant experience serving as the primary correspondent and negotiator with the FDA (CDRH) and European Notified Bodies.
- Proven experience in building, leading, and scaling a global regulatory affairs department.
- Exceptional strategic thinking, problem-solving, and analytical skills.
Preferred Qualifications
- Experience with combination products, software as a medical device (SaMD), or digitally enabled devices is highly desirable.
- Regulatory Affairs Certification (RAC) is a strong plus.
- Experience in a fast-paced, high-growth environment, such as a venture-backed startup or a rapidly expanding public company.
- Excellent written and verbal communication skills, with the ability to clearly articulate complex regulatory concepts to diverse audiences, including boards of directors, investors, and internal teams.
- Strong business acumen with the ability to effectively balance regulatory requirements with commercial objectives.
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, significant annual performance-based bonus, and a meaningful long-term equity/incentive package.
Comprehensive Health & Wellness
Premium medical, dental, and vision insurance plans for you and your dependents, along with wellness programs and resources.
Retirement Planning
A generous 401(k) plan with a substantial company match to help you plan for your future.
Work-Life Balance
An executive-level paid time off (PTO) policy, paid holidays, and flexible work arrangements to support your well-being.
Relocation Support
A comprehensive relocation package is available for the ideal candidate and their family.
Professional Growth
Ample support for continuing education, professional memberships, and attendance at key industry conferences.
Impactful Work
The opportunity to be a pivotal leader in a company dedicated to innovation and improving patient outcomes on a global scale. You will work alongside a passionate and brilliant team committed to making a difference.
How to Apply
JRG Partners is the exclusive recruitment firm managing this executive search. We invite all qualified and interested candidates to submit their curriculum vitae and a cover letter outlining their suitability for this strategic role. Due to the high volume of interest, we will only be able to contact candidates who meet the specified requirements.
To apply, please forward your materials in confidence. If you would like to learn more about our recruitment expertise in this sector, please explore our expertise in Life Sciences executive search. We are an equal opportunity employer and value diversity at our company and the organizations we represent. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
