bioMérieux
Sophie Vernay is an experienced Regulatory Affairs Manager specializing in Molecular Biology at bioMérieux since July 2013, having previously held the role of Regulatory Affairs Specialist. Sophie's expertise includes CE marking and FDA filing for In Vitro Diagnostic Devices, design and change control, and regulatory watch. Prior to bioMérieux, Sophie worked as a Regulatory Affairs Specialist at Kisco International, focusing on CE marking for implantable medical devices and technical documentation implementation following GHTF/IMDRF guidelines. Earlier roles include regulatory support for IVD products in the ASPAC region at bioMérieux, and significant contributions as an Analytical Chemist at Pfizer, Sanofi Aventis, and UCB - Surface Specialties. Sophie holds a Master’s degree in Regulatory Affairs from the University of Lyon and a Master’s degree in Chemistry and Chemical Engineering from CPE Lyon.
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