EMEA/LatAm Regulatory Affairs Leader
W. L. Gore & Associates
Le Cannet, France
Sophie Tabutin, PharmD, MSc joined W. L. Gore & Associates in November 2018 and is leading the Europe, MEA and LatAm regulatory affairs team.
Prior to this, medical devices experience started with BSI Notified Body for 5.5 years. First, as a product reviewer, technical expert, project manager and QMS assessor, providing valuable experience on the technical, regulatory and auditing functions of the Notified Body. Then moved to Notified Body Regulatory Lead position for BSI 0086 in 2015, with active involvement in the preparation work for MDR to allow BSI to reach the key milestones in BSI designation under the MDR and IVDR.
Qualified QP and pharmacist with a background in drug formulation and over twelve years of pharmaceutical industry experience with top pharmaceutical companies in investigational drugs development and clinical research.
Sophie also joined the EU RAPS Board in 2023.
Custom-made and other Personalized Medical Devices: International Regulatory Requirements
Thursday, May 7, 2026
16:45 - 17:45 WEST