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Erica Conway, PhD

Vice President, IVD Regulatory Affairs - Europe
MCRA, United Kingdom

Erica has over 20 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-doctoral 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 in May 2016, to lead the IVD Technical team through transition of the Notified Body (NB) to the new EU IVD Regulation, leading to the successful designations of BSI UK and BSI NL NBs. Erica led the IVD Technical team for operational delivery of Technical Documentation assessments and expanding the team to meet the increased resource demands under the IVDR. Erica moved into the position of Head of NB – IVD in Oct 2021 and continued to represent the NB on Team NB/NBCG-Med for IVDs.
Erica joined MCRA as Vice President, IVD Regulatory Affairs - Europe in August 2022.

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