senior regulatory affairs Executive

We are seeking a Senior Regulatory Affairs Executive with strong expertise in medical devices. The role involves handling end-to-end regulatory compliance, preparing and submitting dossiers, coordinating with CDSCO, managing product approvals, and ensuring adherence to medical device regulations. Candidate should have good knowledge of MDR, BIS, ISO 13485, and related certifications. Must be capable of independently handling regulatory processes.

Key Responsibilities:

• Preparation & submission of regulatory filings for medical devices
• Coordination with regulatory authorities (CDSCO, BIS)
• Handling technical files, clinical data, and product dossiers
• Keeping up-to-date with regulatory changes
• Ensuring timely approvals & renewals

Requirements:

• Graduate/Postgraduate in Science, Pharmacy, or related field
• Knowledge of Indian and international medical device regulations
• Strong documentation and communication skills

Preference: Candidates with experience in Class A, B, C, or D devices approval process.

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CONTACT - NAINA@9999570297

Job Type: Full-time

Pay: ₹35,000.00 - ₹45,000.00 per month

Schedule:

• Day shift

Work Location: In person