James Shearn

Director, Regulatory Intelligence & Policy at Steris

Speaker, Advisor

James Shearn has a degree in Medical Electronics and has worked in the Medical Devices and In Vitro Diagnostic Devices (IVD) sector for over 30 years. His early career was in medical device research and development, before shifting focus to Regulatory Affairs. Throughout his career James has held roles with several large manufacturers, working in the fields of drug infusion systems, cardiology, diabetes management and sterilisation. In the SME space, he was Vice President Regulatory Affairs & Quality Assurance at Oncimmune, an immunodiagnostics company with a focus on the early detection of cancer and autoantibody profiling of autoimmune and infectious diseases. James has also worked with a number of businesses in the sector as an independent regulatory consultant. In February 2023 he joined STERIS as Director, Regulatory & Quality Compliance, moving into the role of Director, Regulatory Intelligence & Policy at the beginning of 2026.