Abhishek Sharma

Regulatory Consultant EU

Abhishek Sharma stepped in the European Medical Device Industry in 2018 as a consultant with certifications in integrated quality and project management. Since then he has successfully supported several small and global medical device manufacturers in various mid to long term projects which were integral in obtaining market approvals and maintaining the continued presence of medical devices in global market. In these projects, Abhishek has been involved from acquisition, execution to closure both as project manager and project team member. He has strong understanding of the medical device business as well as affinity towards healthcare innovations. His expertise lies in European Medical Device Laws including MDD and MDR, EU MDD-EU MDR transition, technical documentation, global regulatory affairs as well as integrated quality and project management.

Prior to entering the medical device market, He obtained his PhD in Biochemistry from Ruhr University Bochum Germany, with focus on interdisciplinary research in the field of neurodegenerative disorders, intrinsically disorder proteins and protein unfolding as the underlying issue. During his period as scientific researcher and project coordinator, he collaborated with several international research groups and authored peer reviewed publications.