BIVDA is pleased to inform members that James Barker (Cytocell) has accepted the post of co-chair of the UKCA Subgroup. James will work alongside the existing chair, Emma Barringer.
James is a regulatory professional with almost 20 years of experience in the IVD sector, currently serving as Regulatory Affairs Manager at Oxford Gene Technology (OGT) in Cambridge, UK.
Over the years, he has held a range of roles that has helped build his broad understanding of the IVD regulatory landscape. This includes supporting OGT’s transition from the IVD Directive (98/79/EC) to the IVD Regulation (EU) 2017/746.
In addition, James has developed processes for vigilance, PMS, PMPF, technical documentation, and has worked on and managed international registrations across several regions including North and South America, the Middle East, Eastern Europe and Asia-Pacific. He also serves as a Person Responsible for Regulatory Compliance (PRRC) under the IVDR.
