Kalidoss P is a detail-oriented Regulatory Affairs Specialist with extensive experience in managing regulatory documentation for drug, device, and combination products. From 2019 to 2020, Kalidoss worked as a Regulatory Affairs Specialist at Tata Elxsi, contributing to the creation of technical files in accordance with EU Medical Device Regulation. Their expertise includes developing global regulatory strategies as a Technical Lead at Operon Strategist and overseeing drug-device combination products at Biocon Biologics from 2021 to 2025. Currently, Kalidoss serves as the Manager of Global Regulatory Affairs for Devices at Amgen. Kalidoss holds a Bachelor of Technology in Biomedical Engineering from Pondicherry University.
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