Key Responsibilities:
- Prepare and maintain regulatory documentation for CDSCO registration of Class B, C, and D medical devices (DMF, PMF, and EPSP).
- Coordinate product registrations, submissions, approvals, renewals and regulatory timelines.
- Respond to regulatory authority queries and resolve registration-related issues.
- dentify and comply with regulatory requirements for India and international markets.
- Obtain and maintain Free Sale Certificates (FSCs) and Market Standing Certificates.
- Prepare and compile Minor and Major Post-Approval Change (PAC) dossiers.
- Prepare and maintain product-specific Clinical Evaluation Reports (CERs) in accordance with Indian regulatory requirements.
- Collaborate with cross-functional teams to support regulatory submissions.
- Ensure compliance with ISO 13485 QMS requirements and documentation.
Qualifications:
Job Types: Full-time, Permanent
Pay: ₹25,000.00 - ₹40,000.00 per month
Benefits:
- Food provided
- Health insurance
- Provident Fund
Work Location: In person
