Job Title: Vice President, Regulatory Affairs

Location: London, UK (Hybrid – 2 days per week onsite)

Job Type: Permanent

About the Role

We are seeking an experienced and highly driven Vice President of Regulatory Affairs to lead global regulatory strategy for a Class III medical device portfolio, with a strong focus on cardiovascular products. This is a senior leadership role requiring both strategic oversight and hands-on technical expertise, particularly in technical file preparation and regulatory submissions.

Key Responsibilities

• Lead and execute global regulatory strategies across UK, EU, and US markets
• Provide expert guidance on MDD to MDR transition activities and ongoing MDR compliance
• Act as the primary regulatory liaison with MHRA, EU Notified Bodies, and the US FDA
• Oversee and contribute directly to the preparation, review, and maintenance of technical documentation and design dossiers for Class III devices
• Drive regulatory submission activities including CE marking, MDR submissions, and FDA approvals (e.g., PMA, 510(k) where applicable)
• Ensure compliance with all applicable regulatory standards and guidelines
• Partner cross-functionally with R&D, Clinical, Quality, and Commercial teams
• Lead, mentor, and develop the regulatory affairs team
• Stay current with evolving global regulatory requirements and assess business impact

Required Experience & Qualifications

• Extensive experience in Regulatory Affairs within the medical device industry
• Strong expertise in Class III cardiovascular devices (essential)
• Proven experience with MDD, MDR, MHRA, EU Notified Bodies, and US FDA regulations
• Demonstrated hands-on experience preparing and managing technical files and submissions
• Track record of successful regulatory approvals in EU and US markets
• Deep understanding of clinical and regulatory requirements for high-risk devices
• Strong leadership and stakeholder management skills
• Excellent communication and problem-solving abilities

Desirable

• Experience leading regulatory teams in a global organisation
• Background in cardiovascular or implantable device technologies
• Familiarity with post-market surveillance and vigilance requirements

What We Offer

• Competitive executive salary and benefits package
• Opportunity to shape regulatory strategy for innovative, life-saving technologies
• Collaborative and high-impact leadership environment
• Hybrid working model with London office presence (2 days per week)

If you are a regulatory leader with a passion for advancing cardiovascular medical technologies and thrive in both strategic and hands-on environments, we encourage you to apply.