Wojciech Bobela

Senior Regulatory Affairs Specialist at Novocure

Speaker

Wojciech is a Regulatory and Clinical Affairs Specialist with a strong scientific (MSc in Medical Biotechnology; PhD in Neurobiology), and consulting background. During his consultant career, he provided consulting support to both US and European medical device manufacturers, striving for compliance with the requirements of the EU 2017/745 MDR. His clients ranged from small family companies, through startups to multi international corporations.

Among others, Wojciech was involved in establishment and management of Clinical Evaluation service delivery processes; provision of PMS/PMCF support; clinical/regulatory strategy definition and consulting, as well as delivery of numerous trainings and workshops.

Wojciech holds Diploma of Advanced Studies in Management of Clinical Studies from the University of Geneva, as well as Regulatory Affairs Certification (RAC) for Medical Devices, and Medical Device and Pharmaceuticals (DUAL) Certificate, both obtained from Regulatory Affairs Professionals Society (RAPS).

He is currently involved with Ziemer Ophthalmic Systems AG, where he works as a Clinical Affairs Manager.