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:
M Pharm

Job Types: Full time, Permanent

Pay: ₹25,000.00 - ₹40,000.00 per month

Advantages:
Food provided
Health insurance
Provident Fund

Work Location: In person

📌 Executive Regulatory Affairs Bengaluru
🏢 Blue Neem Medical Devices Private
📍 Bengaluru