Global Head of Regulatory Affairs, Core Lab
Roche Diagnostics GmbH
Stefan Scheib, PhD, Global Head of Regulatory Affairs, CoreLab, at Roche Diagnostics, Germany
He has over 25 years experience in the health care industry and is currently responsible for a Network supporting the Customer Area CoreLab in shaping and defining regulatory strategies, transformations, submissions, Health Authority/ Notified Body interaction, and country interactions on a global level.
In addition to that he is and was active in different roles in the European industry association MTE (MedTech Europe).
He holds a PhD in Organic Chemistry from the University of Würzburg (Germany). After a Post Doc in the US and 4 years with Johnson & Johnson in Switzerland in the API production environment he joined Roche Diagnostics in 2001. After roles in Engineering (Equipment Qualification) and Quality Management (Change Control, Auditing, QMS) he moved into Regulatory Affairs in 2011 (submission and approval of high risk parameters), took over responsibility for one product line in 2014, expanded responsibility for a business segment in 2017 and started in his current role beginning of 2022.
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