Sr. Director of Regulatory Affairs

About the Role

We are seeking a Senior Director of Regulatory Affairs to provide strategic leadership for global regulatory activities supporting a portfolio of Class III medical devices. This individual will define and execute worldwide regulatory strategy, lead U.S. and international submissions, manage regulatory interactions, and serve as a key member of the leadership team supporting product development, clinical studies, commercialization, and lifecycle management.

Responsibilities

• Develop and execute global regulatory strategies for Class III medical devices from concept through commercialization and post-market support.
• Lead FDA regulatory submissions, including PMAs, PMA Supplements, IDEs, annual reports, and other regulatory filings.
• Oversee international regulatory submissions and approvals, including EU MDR, Health Canada, PMDA, TGA, and other global markets.
• Serve as the primary regulatory liaison with FDA, notified bodies, and international regulatory agencies.
• Provide strategic regulatory guidance to Executive Leadership, R&D, Clinical Affairs, Quality, Manufacturing, and Marketing teams.
• Support regulatory strategy for clinical studies and product approvals, including interactions related to investigational and pivotal clinical programs.
• Review and approve regulatory submissions, labeling, technical documentation, risk management files, and product claims.
• Assess regulatory impact of design changes, product enhancements, and new product development initiatives.
• Ensure compliance with global regulatory requirements and communicate evolving regulations across the organization.
• Build, lead, and mentor a high-performing Regulatory Affairs team.
• Represent Regulatory Affairs at executive leadership meetings and contribute to overall business strategy.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or related discipline; advanced degree preferred.
• 15+ years of Regulatory Affairs experience within the medical device industry.
• Extensive Class III medical device experience.
• Proven success leading multiple PMA submissions, PMA supplements, and FDA interactions.
• Deep expertise in both U.S. and international regulatory submissions and approvals.
• Strong knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, EU MDR, and global regulatory requirements.
• Experience supporting clinical trials, IDE submissions, and regulatory strategies for complex medical devices.
• Demonstrated leadership experience managing and developing regulatory teams.
• Strong executive presence with the ability to influence cross-functional and senior leadership stakeholders.

Preferred Qualifications

• RAC certification.
• Experience with cardiovascular, structural heart, electrophysiology, neurovascular, implantable, or other Class III medical devices.
• Prior responsibility for global regulatory strategy across multiple product lines and international markets.
• Experience interacting directly with FDA leadership, notified bodies, and global regulatory agencies.

Ideal Candidate Profile

• 15-20+ years of medical device regulatory affairs experience.
• Extensive PMA and FDA submission expertise.
• Significant experience with international regulatory approvals and global market expansion.
• Proven leader capable of building regulatory organizations and serving as a strategic executive partner.
• Track record of successfully bringing Class III medical devices from development through commercialization and global approval.