Our smaller startup client is adding an accomplished Vice President of Regulatory Affairs and Quality Assurance to lead regulatory and quality strategy for its cardiovascular medical device program. This executive will guide the organization through critical clinical, regulatory, and quality milestones while building the capabilities needed for future commercialization in the United States and international markets.

Near-term priorities include ISO certification, planned 2026 PMA modules covering R&D, manufacturing, and preclinical information, and readiness for anticipated study enrollment in early 2027. The ideal candidate brings direct experience guiding a Class III device from IDE through PMA, global regulatory expertise, and the judgment to advise executive leadership and the Board while remaining closely involved in execution.

Your role with the company:

Own the integrated regulatory and quality strategy, aligning clinical development, product development, manufacturing and commercialization plans with company objectives.

Lead IDE and PMA strategy and submission execution, including modular PMA planning, submission timelines, scientific content, amendments, supplements and approval commitments.

Serve as the senior interface with FDA and other regulatory authorities, leading key meetings, negotiations and responses to regulatory inquiries.

Advise executive leadership and the Board on regulatory pathways, quality risks, development tradeoffs, milestones and resource needs.

Oversee the Quality Management System, ISO certification and inspection readiness, ensuring the established system scales appropriately as the company advances.

Partner with R&D, Manufacturing and Clinical leadership on design controls, risk management, preclinical evidence, clinical research requirements and product quality.

Develop international regulatory strategy for Europe, Canada, Australia, New Zealand, Israel and other priority markets; guide the pathway toward initial CE marking.

Oversee regulatory approvals and commitments supporting U.S. and international clinical studies, including coordination with Clinical on required reporting.

Direct readiness for regulatory and quality inspections, supporting clinical research inspection preparation and corrective action as appropriate.

Assess organizational capabilities, mentor regulatory and quality personnel, and manage consultants, budgets, and resources to support near-term execution and longer-term growth.

Desired Profile:

Bachelor's degree in life sciences, engineering or a related field; advanced degree preferred.

15+ years of combined medical device regulatory and quality experience, with progressive leadership responsibility.

Significant Class III device experience; cardiovascular medical device experience preferred.

Demonstrated leadership of IDE and PMA programs, taking a device from early development through FDA approval.

Direct experience leading FDA interactions, complex submission strategy, and cross-functional regulatory execution.

Deep understanding of applicable FDA requirements, ISO 13485, quality system operations, design controls, risk management, and manufacturing compliance.

Experience implementing or overseeing quality systems, certification readiness, and regulatory inspections.

Global regulatory experience, particularly in Europe, Canada, Australia and New Zealand; experience in Israel is valuable.

Experience developing CE marking strategy and working with Notified Bodies and international clinical research requirements.

Experience in a major medical device organization is strongly preferred, with the ability to adapt its practices to a lean start-up environment.

Executive leadership and Board exposure preferred, along with experience developing teams and managing external regulatory and quality partners.

Leadership Profile

A credible, emotionally intelligent leader who communicates complex issues clearly, builds strong working relationships, and provides practical recommendations to executives and the Board. This person must balance strategic oversight with hands-on involvement, prioritize effectively, and bring discipline to a growing organization without adding unnecessary complexity.