Sr. Director of Regulatory Affairs
Director, Regulatory Affairs - Structural Heart
Position Summary
We are seeking a Director of Regulatory Affairs to lead global regulatory strategy for a growing portfolio of innovative structural heart therapies. This individual will serve as a key member of the leadership team, partnering across R&D, Clinical Affairs, Quality, Marketing, and Executive Leadership to drive regulatory success from product development through commercialization.
The ideal candidate will bring deep expertise in Class III cardiovascular devices, FDA PMA pathways, IDE studies, and global regulatory strategy, with a proven track record of advancing novel structural heart technologies through major regulatory milestones.
Key Responsibilities
- Lead the global Regulatory Affairs function for structural heart products across all stages of development and commercialization.
- Develop and execute regulatory strategies supporting IDEs, PMAs, PMA supplements, international registrations, and product lifecycle management activities.
- Serve as the regulatory lead for next-generation transcatheter valve, repair, replacement, and other structural heart technologies.
- Provide strategic regulatory guidance throughout product development, including design controls, risk management, verification and validation, human factors, and clinical study design.
- Lead interactions with FDA, notified bodies, and international regulatory agencies.
- Partner closely with Clinical Affairs to support IDE clinical trials, PMA submissions, and physician-sponsored research initiatives.
- Evaluate regulatory pathways, risks, and business opportunities for new products, acquisitions, and market expansion efforts.
- Build and mentor a high-performing regulatory affairs team while establishing scalable processes to support organizational growth.
- Represent Regulatory Affairs on executive leadership reviews, portfolio planning discussions, and product development councils.
- Assess regulatory impacts of design changes, manufacturing transfers, supplier changes, and quality system initiatives.
Qualifications
- Bachelor's degree in Engineering, Biology, Life Sciences, Regulatory Affairs, or related discipline.
- 12+ years of medical device Regulatory Affairs experience.
- 5+ years of leadership experience managing regulatory professionals and cross-functional teams.
- Strong experience supporting Class III implantable medical devices.
- Demonstrated success with FDA PMA, IDE, and regulatory agency interactions.
- Deep understanding of Design Controls, Risk Management, Quality Systems, Clinical Affairs, and Product Development.
- Experience developing and executing global regulatory strategies.
Preferred Experience
- Structural Heart experience including TAVR, TMTT, mitral repair, tricuspid repair, LAA closure, heart failure therapies, or catheter-based cardiovascular technologies.
- Experience bringing first-in-class or novel implantable cardiovascular devices through FDA approval.
- Direct experience supporting pivotal IDE studies and PMA submissions.
- International regulatory expertise including EU MDR, Canada, Australia, Japan, and emerging markets.
- RAC certification preferred.
Ideal Candidate Profile
- Regulatory leader from companies such as Edwards Lifesciences, Abbott Structural Heart, Medtronic Structural Heart, Boston Scientific, JenaValve, Cardioband, CroíValve, or other Class III cardiovascular device organizations.
- Proven ability to influence executive leadership and drive regulatory strategy for high-growth medical device companies.
- Comfortable operating in a fast-paced, venture-backed or growth-stage environment preparing for significant clinical, regulatory, and commercial milestones.
Compensation
- Base Salary: $220,000-$300,000+
- Annual Bonus
- Equity/Stock Options
- Comprehensive Benefits Package
- Long-Term Leadership Growth Opportunity
Target keywords: PMA, IDE, Structural Heart, Transcatheter Valve, TAVR, Mitral, Tricuspid, Class III, FDA, Global Regulatory Strategy, Clinical Trials, Product Development, Design Controls, Cardiovascular Devices, Leadership.
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