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.