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:

Job Summary:

Regulatory Affairs professional

Key Responsibilities:

dossiers, Device Master Files (DMF), and technical documentation

product licensing, import/manufacturing approvals

regulatory authorities, notified bodies, and certification agencies

compliance of product labeling, artwork, IFUs, and packaging

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