Stephen Lee is a regulatory affairs leader with over 30 years of experience across government, public sector and industry. He currently serves as Director of Diagnostics & Digital Regulation at the Association of British HealthTech Industries (ABHI), representing over 400 member organisations in discussions with UK regulators and policymakers.

Previously, Stephen held senior roles at the MHRA, contributing to IVD regulatory reform and expert groups on digital health and software. He also chaired the European Commission’s IVD Working Group (2012–2018), helping shape the EU’s IVDR and technical specifications.

In addition to his ABHI role, Stephen is a Board Member at TOPRA and a regulatory adviser at RegMetrics. Colleagues say they value his ability to collaborate, think critically and simplify complex regulation. His work is underpinned by a commitment to professional integrity, inclusion, and supporting the next generation of regulatory professionals.

Stephen is a Chartered Scientist and Fellow of the Institute of Biomedical Science and TOPRA. He has received the TOPRA Award for Regulatory Excellence and regularly contributes to industry guidance, training, and strategic policy work.