Prior to joining MCRA, Dr. Conway has 20+ years of experience in IVD and pharma regulatory affairs, including manufacturing and consulting roles. Former BSI Global Head of IVD, and latterly Head of IVD Notified Body (NB), for 8+ years. At BSI, Dr. Conway was pivotal in the implementation of the IVD Regulation (IVDR, (EU) 2017/246) and the successful designations of both the UK and the Netherlands organizations to the IVDR. Dr. Conway was a decision maker on final certification decisions for all IVDs under IVDD Annex II, self-tests, and IVDs under-going IVDR certification for the first time (including cancer markers, infectious diseases, clinical chemistry and physiological markers).
Dr. Conway has a Bachelor of Science (BSc Hons) in Physiology from the University of Sheffield (1997) and Doctorate of Philosophy (PhD) specializing in neurophysiology from the University of Bristol, UK (2001).
Dr. Conway did a short post-Doctoral position at the University of Cambridge before entering industry.
Dr. Conway has over 20 years of regulatory affairs and quality assurance experience, primarily within In-Vitro Diagnostic (IVD) medical devices. Dr. Conway's industrial experience started in the regulation of pharmaceuticals before moving into clinical trials for medicinal products for a CRO. Dr. Conway moved into the field of IVD medical devices for a diagnostics company before becoming an independent consultant, working within the IVD and medical device field. Dr. Conway joined BSI as a Technical Specialist/Scheme Manager in the IVD medical devices team before assuming the role of Global Head of the IVD Team, leading the IVD Technical team for operational delivery of Technical Documentation assessments and expanding the team to meet the increased resource demands under the IVDR. Her role also included independent final decision making. Dr. Conway moved into the position of Head of IVD NB, where she was responsible for the overall compliance of the NB (and UK Approved Body) for certification of IVDs.
In addition to her leadership role in IVD certification, Dr. Conway represented IVD Notified Bodies on behalf of Team NB/NBCG-Med at MDCG IVD Working group meetings, where she contributed to the development of IVD MDCG guidance, as well as representing NBs in meetings with the European Medicines Agency (EMA) for the development of the Companion Diagnostics consultation process. Dr. Conway has also represented NBs in meetings with agency stakeholders on clinical evidence and procedures for Class D IVDs under IVDR. In addition, she represented BSI at agency and government meetings in relation to the SARS-CoV-2 pandemic, including the assessment of IVDs under the UK Coronavirus Test Device Authorization (CTDA) procedure.
Overview
Dr. Conway is responsible for all regulatory activities associated with IVD medical devices for Europe.