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Fiona Gould

Regulatory Affairs Consultant at Apotech Consulting

Fiona Gould is a seasoned regulatory affairs and quality assurance professional with extensive experience in the IVD sector. Currently serving as a Regulatory Affairs Consultant at Apotech and Debiopharm, Fiona provides regulatory strategy and IVDR support, respectively. As Director of FKG Consultancy Ltd since 2018, Fiona has developed procedures and documentation essential for IVD development. Previous roles include RA/QA Consultant at Global Access Dx, where comprehensive quality management systems and risk management procedures were established, and various regulatory consultancy positions supporting IVDR compliance for multiple organizations. Fiona holds a PhD in Cell and Molecular Biology from the University of Aberdeen, an MSc in Genetics from the University of Glasgow, and a BSc(Hons) in Applied Biological Sciences from the University of the West of England.

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