Steve Lee is an experienced professional in the fields of diagnostics and regulatory affairs, currently serving as the Director of Diagnostics and Digital Regulation at ABHI and a Regulatory Advisor at Reg Metrics. With a strong background in in vitro diagnostic medical devices, Steve has also held senior roles at the Medicines and Healthcare Products Regulatory Agency, focusing on IVDR implementation. Additionally, Steve contributes to regulatory bodies and community initiatives, including serving as Director at TOPRA and on the Board of Governors at Deptford Park School. Educational qualifications include a degree in Biology and Biochemistry from Aston University and various certifications in biomedical sciences and computing. Previous roles include positions as a microbiologist and biomedical scientist, showcasing a robust foundation in microbiological monitoring and laboratory practices.
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TOPRA - The Organisation for Professionals in Regulatory Affairs
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TOPRA, The Organisation for Professionals in Regulatory Affairs, is a non-profit, non-political organisation which seeks to advance the status of the regulatory profession through education and provision of information to its members. Our current membership is drawn from over 50 countries, and members worldwide are actively involved in delivering the services needed by busy regulatory specialists. Members are drawn from industry, regulatory agencies and the consultancy community, and work in all sectors including medical technologies, biotech, borderline products and pharmaceuticals.