Regulatory Affairs Specialist (Medical Devices)

Role Overview : Responsible for preparing, reviewing, and maintaining regulatory submissions and product registrations to ensure compliance with CDSCO, US FDA, and EU MDR requirements. Key Responsibilities : Prepare and compile regulatory submissions (e.G., Device Master File, Technical File, 510(k), CE marking, etc.). Ensure compliance with ISO 13485, EU MDR 2017 / 745, US FDA 21 CFR Part 820, and local regulatory guidelines. Review labeling, IFUs, and promotional materials for compliance. Manage product registration, renewals, and post-market submissions. Monitor regulatory updates and standards relevant to medical devices. Support internal and external audits, providing necessary documentation. Collaborate with R&D, QA, and manufacturing teams for regulatory input. Qualifications : B.Pharm / M.Pharm / M.Sc (Regulatory Affairs, Biotechnology, or Life Sciences). Minimum 6 years’ experience in Regulatory Affairs for medical devices. Strong knowledge of device registration process and QMS standards. Experience interacting with Notified Bodies / Regulatory Authorities preferred.