Mirela Boureanu

Mirela Boureanu is an experienced professional in regulatory affairs and quality management, currently serving as the Regulatory Lead for MDR & UKCA at BSI since September 2018. In this role, Mirela manages activities for the UK Approved Body and the EU Notified Body, focusing on audits, competency reviews, and document control processes while actively engaging with MHRA on UKCA conformity. Prior to this, Mirela held positions at SGS, overseeing MDSAP certifications and ISO 13485 as a Global Product Manager, and worked as a Company Director at Optima Consulting Ltd. Further experience includes roles at CareFusion UK, Zimmer, and Stryker, where Mirela developed quality management systems and conducted internal audits. Academic credentials include a Master’s in Medical Engineering from Université Claude Bernard Lyon 1 and a degree in Biomedical Engineering from Universitatea de Medicină și Farmacie „Grigore T. Popa” din Iași.