James Shearn

Director, Regulatory & Quality Compliance (EMEA) at Steris

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 28 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. James has also worked as an independent regulatory consultant, predominantly with Small and Medium Sized Enterprises (SMEs) and as VP Regulatory Affairs & Quality Assurance for Oncimmune, an SME in the immunodiagnostic IVD space. James joined STERIS in February 2023 as Director, Regulatory & Quality Compliance, heading the regulatory function in the EMEA region for healthcare and life science products.