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.