Erica has over 13 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-doc, Erica’s industrial experience started at GSK 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 IVDs when she became the Regulatory Affairs Manager for Axis-Shield Diagnostics (now Alere). She then went into performing independent consultancy work and continued working within the IVD and medical device field, as a continued member of BIVDA. Erica worked for a small start-up IVD company prior to joining BSI, where she set up a Quality Management System to ISO 13485 and ISO 17025.
Erica joined BSI at the beginning of 2014, and is now Global Head of IVDs, using her experience to transition the Notified Body to the IVD Regulation.
