Director of Regulatory Affairs
Director, Regulatory Affairs (Cardiovascular / Electrophysiology)
Location: Orange County
Company Overview
Our client is an innovative cardiovascular medical device company developing next-generation technologies for the treatment of cardiac arrhythmias. The organization is focused on advancing electrophysiology (EP), cardiac mapping, and catheter-based ablation technologies to improve outcomes for patients with atrial fibrillation and other rhythm disorders. The company is building novel solutions that integrate mapping, navigation, and ablation capabilities to support physicians during complex EP procedures.
Position Summary
The Director of Regulatory Affairs will provide leadership for global regulatory strategy and execution across a portfolio of Class III cardiovascular devices. This individual will serve as a key regulatory leader supporting product development, clinical studies, and commercialization efforts in the United States and internationally. The role requires close collaboration with R&D, Clinical Affairs, Quality, Marketing, and Executive Leadership to ensure successful regulatory approvals and market access.
Key Responsibilities
- Develop and execute global regulatory strategies for cardiovascular and electrophysiology medical devices.
- Lead FDA interactions including Pre-Subs, IDEs, PMAs, PMA Supplements, and post-approval commitments.
- Provide regulatory guidance throughout product development, design changes, verification/validation, and commercialization activities.
- Serve as the regulatory representative on cross-functional product development teams.
- Prepare and review complex regulatory submissions, ensuring compliance with FDA, EU MDR, and other international requirements.
- Partner with Clinical Affairs to support clinical trial strategy, protocol development, and regulatory approvals.
- Lead communications and negotiations with regulatory agencies worldwide.
- Assess regulatory risks and develop mitigation strategies to support business objectives.
- Support quality system compliance and regulatory inspections as needed.
- Build and mentor a growing regulatory affairs team.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or related field.
- 10+ years of Regulatory Affairs experience within the medical device industry.
- Experience supporting Class III devices through FDA approval pathways.
- Hands-on experience with PMAs, PMA Supplements, IDEs, and FDA agency interactions.
- Strong knowledge of design controls, risk management, and product lifecycle management.
- Experience supporting global regulatory submissions, including EU MDR.
- Demonstrated ability to influence executive leadership and cross-functional stakeholders.
- Must have cardiovascular experience
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