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 submit regulatory dossiers for product approvals and renewals.
• Develop and maintain Technical Files, DMR, and DHF .
• Ensure compliance with CDSCO, FDA 21 CFR Part 820, and EU MDR .
• Review labeling, IFUs, and promotional materials for compliance.
• 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 :