Head of Regulatory Affairs / Vice President, Regulatory Affairs (Irvine)

Head of Regulatory Affairs / Vice President, Regulatory Affairs

Location: Southern California (Onsite/Hybrid)

Industry: Cardiovascular Medical Devices

Position Overview

We are seeking a strategic and hands‑on Head of Regulatory Affairs / Vice President of Regulatory Affairs to lead global regulatory strategy for a growing cardiovascular medical device company. This executive leader will be responsible for developing and executing worldwide regulatory strategies across product development, clinical, commercialization, and lifecycle management activities. The ideal candidate brings deep expertise in both U.S. and international regulatory submissions, with a proven track record of successfully bringing Class II and Class III medical devices to market.

This individual will serve as a key member of the leadership team, partnering closely with R&D, Clinical, Quality, Manufacturing, Marketing, and Executive Management to ensure regulatory objectives align with business goals.

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.

What We’re Looking For

• Strategic leader capable of building a world‑class regulatory function.
• Strong business acumen with the ability to balance regulatory requirements and commercial objectives.
• Collaborative executive who thrives in a fast‑paced, innovation‑driven environment.
• Hands‑on leader willing to engage at both the strategic and operational levels.
• Passion for advancing innovative cardiovascular technologies that improve patient outcomes.

Location Requirement: Candidates must currently reside in, or be willing to relocate to, the Southern California area. Travel may be required domestically and internationally.