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.

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