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.
FAQs
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