Role Overview for VP Quality & Regulatory Affairs, Cardiovascular Devices – Boston, MA
JRG Partners is proud to partner with a pioneering, venture-backed medical device company at the forefront of cardiovascular innovation. Located in the heart of Boston’s thriving life sciences ecosystem, our client is developing a revolutionary portfolio of Class III cardiovascular devices poised to redefine standards of care and improve patient outcomes globally. We are seeking a visionary and strategic Vice President of Quality & Regulatory Affairs to join their executive leadership team. This is a pivotal role responsible for architecting and executing the global quality and regulatory strategy that will guide the company from late-stage development through commercialization and beyond.
As the VP of Quality & Regulatory Affairs, you will be the ultimate authority on compliance, ensuring that all products and processes meet the highest standards of safety and efficacy. You will provide critical guidance to the CEO and the board, shaping the company’s approach to navigating complex international regulatory landscapes, including the FDA, EU (MDR), and other key markets. Your leadership will be instrumental in building a world-class Quality Management System (QMS), fostering a culture of quality-first across the organization, and leading successful interactions with regulatory bodies. This position demands a leader with deep expertise in high-risk cardiovascular devices, a proven track record of successful PMA submissions, and the strategic acumen to balance regulatory compliance with ambitious business objectives. You will be empowered to build and mentor a high-performing team, establish robust processes, and make a tangible impact on a company set to disrupt the cardiovascular space.
Key Responsibilities of VP Quality & Regulatory Affairs, Cardiovascular Devices – Boston, MA
The Vice President of Quality & Regulatory Affairs 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 approach combined with high-level strategic thinking.
Strategic & Executive Leadership
- Develop, implement, and lead the company’s global quality and regulatory strategy in alignment with corporate goals for product development, clinical trials, and commercial launch.
- Serve as a key member of the executive team, providing expert counsel on regulatory risks, compliance requirements, and strategic opportunities.
- Establish and manage the departmental budget, resource allocation, and long-range planning to support a growing product portfolio.
- Act as the primary liaison with regulatory authorities, including the FDA, Notified Bodies, and other international agencies, fostering positive and productive relationships.
- Champion a proactive, compliance-oriented culture throughout the entire organization, from R&D to manufacturing and commercial operations.
- Present quality and regulatory strategies, updates, and milestones to the executive team and Board of Directors.
Regulatory Affairs
- Direct all global regulatory submission activities, with a primary focus on Pre-Market Approval (PMA) applications for Class III cardiovascular devices in the US.
- Formulate and execute strategies for international registrations, including CE Marking under the EU Medical Device Regulation (MDR) and submissions in other key markets like Japan, Canada, and China.
- Oversee the preparation, review, and submission of all regulatory filings, including Investigational Device Exemptions (IDEs), 510(k)s, PMAs, technical files, design dossiers, and supplements.
- Manage all communications and interactions with regulatory agencies, leading meetings, responding to inquiries, and negotiating submission requirements and approval pathways.
- Develop and maintain a robust regulatory intelligence program to monitor changes in the global regulatory environment and assess their impact on the business.
- Provide regulatory oversight for clinical trial design and execution, ensuring compliance with GCP and applicable regulations.
- Direct post-market surveillance, vigilance, and adverse event reporting systems to ensure timely and accurate compliance.
Quality Assurance & Compliance
- Provide ultimate oversight for the development, implementation, and maintenance of a compliant and efficient Quality Management System (QMS).
- Ensure the QMS adheres to all applicable standards, including the FDA’s Quality System Regulation (QSR) under 21 CFR Part 820, ISO 13485, EU MDR, and other relevant international requirements.
- Lead the company’s readiness for and management of all internal and external audits and inspections by regulatory bodies (e.g., FDA, Notified Bodies).
- Oversee all core quality system elements, including but not limited to: Design Controls, Risk Management (ISO 14971), Document Control, CAPA (Corrective and Preventive Action), Complaint Handling, and Production and Process Controls (P&PC).
- Direct the supplier quality management program, including supplier qualification, auditing, and performance monitoring to ensure the integrity of the supply chain.
- Ensure robust validation strategies are in place for all processes, equipment, and software (IQ/OQ/PQ).
- Establish and monitor key quality metrics; report on the performance of the QMS to executive management as part of the management review process.
Requirements for the VP Quality & Regulatory Affairs, Cardiovascular Devices – Boston, MA
We are seeking a seasoned and accomplished leader with a deep and specific background in the medical device industry. The ideal candidate will possess the following qualifications and experience:
Education & Experience
- A minimum of a Bachelor’s degree in a scientific, engineering, or related technical field is required. An advanced degree (MS, PhD, or MBA) is highly preferred.
- 15+ years of progressive experience in Quality Assurance and Regulatory Affairs within the medical device industry.
- A minimum of 7-10 years in a senior leadership role (Director level or above) with proven experience building and managing high-performing teams.
- Direct, hands-on experience with Class III, high-risk medical devices is mandatory. Specific experience with cardiovascular devices (e.g., structural heart, interventional cardiology, electrophysiology, or vascular implants) is strongly required.
- Demonstrated track record of successfully authoring, submitting, and gaining approval for PMA applications with the FDA.
- Extensive experience leading successful interactions and negotiations with the FDA (CDRH), Notified Bodies, and other global regulatory agencies.
- Experience in a fast-paced, start-up or small company environment is highly desirable.
Skills & Competencies
- Expert-level knowledge of global medical device regulations and standards, including 21 CFR 820, 21 CFR 812, EU MDR 2017/745, ISO 13485, and ISO 14971.
- Exceptional strategic thinking and problem-solving skills, with the ability to develop innovative solutions to complex regulatory challenges.
- Outstanding leadership and people management skills, with a talent for mentoring, coaching, and developing staff.
- Excellent written and verbal communication skills, with the ability to articulate complex concepts clearly and persuasively to diverse audiences, including regulators, executives, and technical teams.
- Strong business acumen and the ability to integrate quality and regulatory compliance into the broader business strategy.
- Unwavering ethical standards, integrity, and a commitment to patient safety and product quality.
Benefits & Perks Offered
Our client offers a highly competitive compensation and benefits package designed to attract and retain top-tier executive talent. This includes:
Competitive Salary
A compelling base salary commensurate with experience and market standards.
Executive Bonus Plan
A significant annual performance-based bonus opportunity.
Equity Participation
A meaningful stock option package, providing a stake in the company’s long-term success.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your dependents.
Retirement Savings
A 401(k) plan with a generous company match.
Generous Paid Time Off
A flexible and generous PTO policy, including vacation, sick days, and company holidays.
Professional Development
Support for continuing education, professional certifications, and attendance at industry conferences.
Relocation Assistance
A comprehensive relocation package is available for the right candidate.
Dynamic Work Environment
An opportunity to work with a brilliant, passionate team in a collaborative and innovative culture.
How to Apply
This is a unique opportunity to shape the future of cardiovascular treatment and build a lasting legacy. If you are a strategic leader with the requisite experience and a passion for innovation, we encourage you to apply. JRG Partners is managing this exclusive search. To be considered for this critical role, please submit your resume and a cover letter detailing your relevant experience. For more information on our expertise in this sector, please visit our Top Cardiovascular Device Executive Search Firm practice area. We look forward to reviewing your application.
