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Beatriz Rodriguez Grande, PhD

Regulatory Consultant
NAMSA
Madrid, Madrid, Spain

Beatriz has a broad interest in healthcare, which has led to 15 years of experience across Regulatory, Medical Affairs and Academic Research. She is currently working in Regulatory Consulting within NAMSA with an EU focus. She has expert competence in European Medical Device Regulation (MDR 2017/745), In Vitro Diagnostic Regulation (IVDR 2017/746) and MEDDEV/MDCG guidance documents. Previously working as manager of the Regulatory Affairs department of a smaller consulting firm, she hired and trained a team of +10 Regulatory Scientists, having delivered projects including strategic consulting, clinical evaluations, MDD to MDR gap assessments, literature reviews, SSCPs, post-market documentation and technical documentation. Beatriz also teaches at several local University Master´s programs with a focus on MD and IVD.
Before getting involved in the Regulatory side of industry, she worked as Clinical Study Manager, gaining solid knowledge of ISO 14155, and worked in Medical Affairs in Pharma, which has given her a broad view of the Pharma and MedTech industry and the critical interactions between the different stakeholders.
Beatriz graduated as a Biochemist (BSc Autonomous University of Madrid, Spain) and holds a PhD in Neuroscience (The University of Manchester, UK), an MSc in Clinical Research and Pharmaceutical Medicine (EPHOS, Spain), and an MRes in Medical and Molecular Bioscience (University of Newcastle, UK).

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