Director, Regulatory Affairs (Electrophysiology)

Location: Minneapolis, MN (Hybrid on site)

Medical Device background needed

Position Summary

We are seeking a Director of Regulatory Affairs to lead global regulatory strategy for a growing portfolio of electrophysiology technologies. This individual will be responsible for developing and executing regulatory strategies across product development, clinical studies, regulatory submissions, and commercial lifecycle management. The Director will partner closely with R&D, Clinical, Quality, Manufacturing, and Executive Leadership to ensure successful product approvals and market expansion.

Responsibilities

• Lead global regulatory strategy for electrophysiology products from concept through commercialization.
• Develop and execute regulatory pathways for FDA, EU MDR, Health Canada, and other international markets.
• Author, review, and oversee complex regulatory submissions, including PMAs, 510(k)s, IDEs, technical documentation, and regulatory responses.
• Serve as the primary regulatory representative during FDA and international health authority interactions.
• Provide regulatory guidance for product development, design changes, labeling, risk management, and clinical studies.
• Partner with Clinical Affairs to support IDE studies, PMA approvals, and post-market commitments.
• Collaborate with Quality and Engineering teams to ensure compliance with applicable regulations and standards.
• Monitor evolving regulatory requirements and assess impact on business and product strategy.
• Build, mentor, and develop regulatory affairs team members.
• Support due diligence activities, acquisitions, and strategic business initiatives as needed.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related discipline; advanced degree preferred.
• 10+ years of Regulatory Affairs experience within medical devices.
• 5+ years of leadership experience managing regulatory teams and strategic programs.
• Direct experience with electrophysiology, cardiac rhythm management, ablation, mapping, structural heart, neurovascular, or other Class III medical devices.
• Significant FDA experience, including PMA, IDE, and regulatory meeting participation.
• Strong knowledge of FDA regulations, EU MDR, ISO 13485, and global regulatory requirements.
• Proven track record leading regulatory strategy for complex product development programs.
• Excellent communication and cross-functional leadership skills.

Preferred Experience

• Electrophysiology mapping systems
• Cardiac ablation catheters
• Cardiac rhythm management devices
• Structural heart technologies
• Implantable or catheter-based Class III medical devices
• Successful PMA approvals and FDA panel experience