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.