Satya Prakash Ojha

About Satya Prakash Ojha

I am a dedicated Medical Device Reporting (MDR) and Vigilance Specialist with 4+ years of…

Experience

1. Senior Mdr Specialist

   美敦力

   Jun 2022 — Present · Hyderabad, IN

   Responsible for evaluating complaints for medical devices across various portfolios like diabetes management, surgical innovations, cardiovascular, etc. Reporting complaints as per regulatory requirements to regulatory authorities such as the FDA, EU MDR, and other local regional authorities across the globe. Identifies complaint risk/investigation level based on reportability decisions made. Notifies investigators of reportability decision changes that would affect the investigation level initially established. Upon receipt of additional information that impacts the initial reportability decision & determines the effects of the initial reportability decision. Notifies country representatives of reported Confidential events that occurred outside of their country but involve products that are approved and registered in their country and their country. Creates and reviews the Alternative Summary Report for submission. Responsible for providing for eMDR/MedWatch Report and Health Canada Vigilance – Medical Device Reporting Program. Evaluate any modification, revision, and/or review of new complaint information for which a closed complaint may require reopening. Responsible for the maintenance of Reportability Guidance Document. Identifying reportability status based on new information received. Providing inputs to the new product development team based on complaint inputs. Distributing and managing workload to applicable team members and reviewing them.