James Shearn

Director, Regulatory & Quality Compliance (EMEA) 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 more than 27 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 and diabetes management. His most recent IVD space roles 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 as an independent regulatory consultant, predominantly with Small and Medium Sized Enterprises (SMEs). In February 2023, joined Steris as Director, Regulatory & Quality Compliance (EMEA).