Assistant Manager - Regulatory Affairs

📍 Location: IMT Manesar, Sector 5, Gurugram, Haryana

💼 Experience: 5–7 Years (Relevant experience in Medical Device Regulatory Affairs preferred)

• Manage CDSCO regulatory submissions, product registrations, licensing, and post-approval changes.
• Prepare and review regulatory dossiers and technical documentation.
• Ensure compliance with ISO 13485 and applicable regulatory requirements.
• Coordinate with cross-functional teams and regulatory authorities.
• Support regulatory compliance for medical device products.

• Mandatory experience in Medical Device Regulatory Affairs.
• Hands-on experience with CDSCO, SUGAM Portal, regulatory filings, licensing, and ISO 13485.
• Candidates from Medical Devices, Pharmaceuticals, Biotechnology, Biologics, or Life Sciences backgrounds are preferred.
• Basic knowledge of biologics is an added advantage.

📩 Apply by sending your updated resume to: [email protected]