Regulatory Affairs Manager

Company Description

Established in 1995, Rapid Diagnostics Group of Companies is a leading provider of diagnostic and health care products in India. Under the leadership of founder Dr. Jindal, we have expanded to 30 branch offices with 400 employees serving nationwide. Initially the Executive Distributor of Sigma Diagnostics, USA, we now sell around 500 products. Our focus on goal-oriented efforts and customer satisfaction has earned us a sterling reputation. With a turnover exceeding 25 million USD and 60% average growth over the past 10 years, we boast a large dealer network with over 3200 distributors in India and neighboring countries.

Regulatory Affairs Manager – IVD / Medical Devices / Diagnostics

Location : [Insert Location] | Department : Quality Assurance & Regulatory Affairs (QA / RA)

Job Summary :

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

Skills Required

Iso 13485, Ce, Gmp, dossier preparation , Ms Office, Regulatory Submissions, DCGI