Director of Regulatory Affairs
Director, Regulatory Affairs - Structural Heart
Location: Minneapolis, MN
Reports To: Vice President, Regulatory Affairs
* Medical device background only
Position Summary
We are seeking a Director of Regulatory Affairs to lead global regulatory strategy and execution for a portfolio of innovative structural heart medical devices. This individual will be responsible for driving regulatory activities across product development, clinical studies, regulatory approvals, and commercialization efforts while ensuring compliance with FDA, EU MDR, and international regulatory requirements. The ideal candidate will bring deep expertise in Class III cardiovascular and structural heart devices, particularly heart valve technologies, and will play a critical role in supporting the company's growth and innovation initiatives.
Key Responsibilities
- Develop and execute global regulatory strategies for structural heart products, including transcatheter valve therapies, repair devices, delivery systems, and related technologies.
- Lead regulatory strategy for structural heart valve therapies, including TAVR/TAVI, transcatheter mitral and tricuspid repair and replacement systems, from development through commercialization.
- Lead regulatory activities for new product development programs from concept through commercialization.
- Serve as the primary regulatory representative on cross-functional teams, partnering closely with R&D, Clinical Affairs, Quality, Manufacturing, Marketing, and Executive Leadership.
- Provide strategic guidance on FDA, EU MDR, Health Canada, and other international regulatory requirements.
- Lead preparation and submission of regulatory filings, including PMAs, IDEs, PMA Supplements, 510(k)s, Technical Documentation, CE Mark submissions, and international registrations.
- Support regulatory aspects of clinical trial design, protocol development, statistical analysis plans, and interactions with regulatory authorities.
- Represent the company during FDA meetings, advisory panel discussions, Notified Body interactions, audits, and inspections.
- Drive regulatory strategy for next-generation structural heart technologies and emerging cardiovascular therapies.
- Monitor evolving regulatory requirements and assess business impact across the product portfolio.
- Provide regulatory due diligence support for acquisitions, partnerships, licensing opportunities, and strategic initiatives.
- Develop, mentor, and lead Regulatory Affairs professionals while fostering a high-performance and collaborative culture.
- Ensure regulatory deliverables align with business objectives, corporate milestones, and product development timelines.
Qualifications
- Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related discipline; advanced degree preferred.
- 10+ years of Regulatory Affairs experience within the medical device industry.
- 5+ years of people leadership experience managing regulatory professionals and cross-functional teams.
- Strong experience supporting Class III cardiovascular or structural heart medical devices.
- Direct experience supporting heart valve technologies, including TAVR/TAVI, surgical valves, transcatheter mitral valve repair/replacement (TMVR), tricuspid valve therapies, and related structural heart interventions strongly preferred.
- Demonstrated success leading PMA, IDE, PMA Supplement, and international regulatory submissions from strategy through approval.
- Deep understanding of FDA regulations, 21 CFR Part 820, ISO 13485, EU MDR, and other global regulatory requirements.
- Experience supporting clinical studies and interacting directly with regulatory agencies and notified bodies.
- Strong knowledge of structural heart technologies, including transcatheter valve replacement, mitral and tricuspid repair systems, left atrial appendage closure devices, occlusion technologies, and other cardiovascular interventions.
- Proven ability to influence stakeholders and drive regulatory strategy within a fast-paced product development environment.
- RAC certification preferred.
FAQs
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