Head of Regulatory Affairs / Vice President, Regulatory Affairs

Key Responsibilities

• Develop and lead global regulatory strategies supporting new product development, clinical studies, product registrations, and commercialization efforts.
• Provide regulatory leadership for U.S. FDA submissions, including PMA, IDE, 510(k), De Novo, PMA supplements, and pre-submission activities.
• Lead international regulatory submissions and market access activities, including EU MDR, Health Canada, TGA, PMDA, UKCA, and other global regulatory agencies.
• Act as the primary regulatory representative with global health authorities and notified bodies.
• Build and manage regulatory affairs teams while fostering a high-performance and collaborative culture.
• Partner with executive leadership to assess regulatory risks and opportunities associated with strategic initiatives.
• Drive regulatory input throughout the product development lifecycle in accordance with design control requirements and applicable global regulations.
• Provide guidance on changing global regulatory requirements and ensure organizational compliance.
• Support due diligence activities, licensing opportunities, acquisitions, and strategic partnerships as needed.
• Collaborate with Clinical, Quality, and Engineering teams to support clinical trial applications, product approvals, and post-market activities.
• Represent Regulatory Affairs during management reviews, audits, inspections, and executive-level decision-making processes.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or a related technical discipline. Advanced degree preferred.
• 15+ years of Regulatory Affairs experience within the medical device industry.
• Proven leadership experience at the Director, Senior Director, VP, or Head of Regulatory Affairs level.
• Extensive experience supporting cardiovascular medical devices, including implantable, structural heart, electrophysiology, vascular, cardiac rhythm management, or related technologies.
• Demonstrated success leading U.S. FDA submissions, including PMA, IDE, and/or 510(k) approvals.
• Strong international regulatory experience, including EU MDR and major global markets.
• Experience developing regulatory strategies from concept through commercialization.
• Strong understanding of FDA regulations, ISO 13485, ISO 14971, EU MDR, and global regulatory frameworks.
• Previous experience leading regulatory interactions with FDA, notified bodies, and international regulatory agencies.
• Excellent executive communication, leadership, and cross-functional influencing skills.

Preferred Qualifications

• Experience supporting first-in-human studies and pivotal clinical trials.
• Background working within high-growth, venture-backed, or publicly traded medical device organizations.
• Experience with global product launches and regulatory approvals across multiple geographies.
• RAC certification and/or advanced scientific or engineering degree preferred.