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 :