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VenkateshMedical Devices and Drug Regulatory Affairs
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With around 9 years 6 months of experience in Medical Device and Pharmaceutical Regulatory Affairs, I have handled Global registration support & EU MDR transition for Medical Devices and Initial registrations for EU & ROW countries and Post-approval submissions like EU CMC variation & US Annual Report for Pharmaceuticals. I can help students in preparation for a Global Regulatory Strategy. I can guide students on how to classify a Medical Device. I use PowerPoint to teach students online. I use flowcharts and other pictorial methods in presentations to make it easy to understand. I explain the topic in simple bullets and provide reference to the topic as a link for quick reference. Also, I will try to explain the topic with a relevant example to make it easy to understand. Since I have actual hands-on professional experience in both Medical Devices and Pharma Regulatory affairs, I can help students with the current date practices within the industry.
Subjects
Drug Regulatory Affairs Beginner-Expert
Pharmaceutical Regulatory Affairs Beginner-Expert
Experience
Specialist - Medical Device Regulatory Affairs (Jan, 2020–Apr, 2023) at ClinChoice India Pvt Ltd, Hyderabad
Senior Consultant - Medical Device Regulatory Affairs (Jan, 2018–Dec, 2019) at Marlabs, Inc. Bangalore