Global Head - In Vitro Diagnostic Medical Devices
Erica has over 15 years experience in the In Vitro Diagnostic (IVD) medical device and pharmaceutical industries, within Regulatory Affairs and Quality Assurance. Following a BSc (Hons), PhD (Neurophysiology) and Post-doctural research, Erica’s industrial experience started at GlaxoSmithKline in the regulation of pharmaceuticals. Further she worked in the arena of clinical trials for medicinal products for Quintiles. Erica then moved into the field of IVD medical devices when she became the Regulatory Affairs Manager for Axis-Shield Diagnostics (Alere Toxicology, now Abbott). She then went into performing independent consultancy work and continued working within the IVD and medical device field, as a continued member of British IVD Association, prior to joining BSI. Erica joined BSI at the beginning of 2014 as a Technical Specialist/Scheme Manager in the IVD medical devices team. She took the position of Global Head of the IVD Medical Device Team June 2016, to lead the IVD Technical team. Erica is currently using her experience to transition the Notified Body (NB) to the new EU IVD Regulation and expand the technical team for the increased demands of the NB under the IVDR. She is a co-chair of the IVD NB working group for NB-Med/Team-NB.
Monday, September 14, 2020
10:00 AM – 11:30 AM EDT
Tuesday, September 15, 2020
9:35 AM – 10:30 AM EDT