Rapid Diagnostic - Regulatory Affairs Manager

Key Responsibilities :

• Prepare and submit dossiers, Device Master Files (DMF), and technical documentation as per CDSCO / DCGI guidelines.
• Manage product licensing, import / manufacturing approvals, and timely renewals.
• Liaise with regulatory authorities, notified bodies, and certification agencies for approvals and audits.
• Ensure compliance of product labeling, artwork, IFUs, and packaging with MDR 2017 & ISO 13485.
• Maintain regulatory databases, product master files, and documentation systems.
• Coordinate with R&D, QA, Production, and Marketing teams for product and regulatory compliance.
• Support internal & external audits (CDSCO, ISO 13485, WHO-GMP) and handle audit responses.
• Stay updated with regulatory changes and market access requirements for IVD and Medical Devices.

Key Skills & Competencies : .

• In-depth knowledge of Medical Device Rules (MDR 2017), ISO 13485, and GMP.
• Strong documentation, communication, and coordination skills.
• Experience in dossier preparation, product registration, and compliance strategy.
• Hands-on experience with Sugam portal and regulatory submissions.
• Proficiency in MS Office, QMS & document control systems.

Qualification & Experience : Education : B Pharm / M. Pharm / M.Sc. (Biotech / Microbiology / Life Sciences) / B. Tech (Biomedical).

Experience : 7-12 years in Regulatory Affairs (IVD / Medical Devices / Diagnostics industry).

Certifications : ISO 13485 / MDR 2017 / QMS awareness preferred.

Keywords for Better Reach : .

Regulatory Affairs | CDSCO | DCGI | ISO 13485 | Medical Devices | IVD | Diagnostics | MDR 2017 | Product Registration | Regulatory Compliance | QA / RA | GMP | Device Master File.

(ref : iimjobs.com)