Rapid Diagnostic - Regulatory Affairs Manager

- Looking for an experienced Regulatory Affairs professional to lead product registration, compliance, and licensing for IVD kits, reagents, and medical devices.

- The ideal candidate should have strong knowledge of CDSCO, DCGI, ISO 13485, CE, and global IVD regulations.

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.