Ensures compliance with MDR 2017 and global regulations.
Manages CDSCO submissions, authority liaison, and core technical docs.
Tracks regulatory updates; works with QA/R&D; to enable protected market access for SaMD & implants.
Required Candidate profile
B.Pharm/M.Pharm with 5+ years of experience in Pharma.
Solid understanding of medical device regulations (India, EU, US).
Knowledge of Medical Device Software (SaMD) regulations is a plus.