Sr. Director of Regulatory Affairs

Senior Director, Regulatory Affairs
Location: San Diego, CA

Position Summary

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 be responsible for defining and executing worldwide regulatory strategy, leading U.S. and international submissions, managing regulatory interactions, and serving as a key member of the leadership team supporting product development, clinical studies, commercialization, and lifecycle management.

Key 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.

Required Qualifications

* 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.