Head of Regulatory - Senior Leadership - MedTech

Head of Regulatory Affairs – Ground-breaking, Highly Complex Medical Technologies Are you ready to lead in a fast-paced, innovative environment at the forefront of medical technology? This is your opportunity to join a globally ambitious company, spearheading regulatory excellence while driving compliance for highly complex, active (electro-mechanical, software, and AI-driven) medical device technologies. Location: Cambridge, UK. Applicants must be UK-based or willing to relocate with the right to work in the UK. Ideally seeking professionals willing to be on-site in a hybrid capacity. Exceptional applicants seeking remote will also be considered. Salary: £150-£200,000 per annum plus a generous benefits package including shares, bonus and non-contributory pension. Company: Ground-breaking, award-winning developer of high-end, complex medical technologies – recently secured De-Novo approval with ambitious plans to scale globally. Why Apply?

• Lead with Impact: Coach, mentor, and grow a high-performing regulatory team, fostering a culture of collaboration and excellence.
• Strategic Influence: Develop and implement global regulatory strategies for advanced Class IIb/III medical devices.
• Global Reach: Manage regulatory approvals and post-market activities across Europe, the USA, China, Japan, and beyond.
• Exceptional Rewards: Competitive salary (£150,000–£200,000) plus a generous benefits package, including shares, a non-contributory pension, and more.

What You'll Do:

• Implement regulatory strategies that align with business goals and ensure global compliance.
• Lead submissions to regulatory bodies, including the FDA and CE marking processes, for cutting-edge electro-mechanical and software-driven medical devices.
• Oversee post-market surveillance activities, including complaint handling, adverse incident reporting, and product recalls.
• Act as the regulatory representative with agencies and partners, influencing outcomes and building valuable relationships.
• Provide leadership and mentoring to the regulatory team, driving best practices and continuous improvement.

What We’re Looking For:

• Extensive senior-level experience in medical device regulatory affairs, with a proven track record of gaining global approvals.
• Expertise in FDA and CE regulatory processes, particularly for complex, active devices.
• Experience in post-market surveillance and compliance across major markets.
• Knowledge of international markets (e.g., China, South Korea, Japan) is highly desirable.
• Strong leadership and team development skills, with the ability to inspire and mentor.

About You: You thrive in high-growth environments and have a passion for leading teams to success. With substantial experience in regulatory affairs within MedTech, you’re ready to take on the challenges of complex Class IIb/III devices, combining strategic vision with hands-on expertise. The Opportunity: Join a company where ambition meets innovation, and where your leadership will make a lasting impact. If you’re ready to help shape the future of MedTech innovation, we’d love to hear from you. Apply now to lead, inspire, and innovate.