Manager-Regulatory Affairs

4 weeks ago


Noida, India Enterslice Full time

Job Title: Manager – Regulatory Affairs (CDSCO)

Location: Sector-60, Noida

Company: Corpbiz ( A unit of Enterslice Private Limited)

Job Description:

We are seeking an experienced Manager – Regulatory Affairs specializing in CDSCO compliance and related regulatory domains. The ideal candidate will handle end-to-end documentation, submission, and approvals for Medical Devices, IVDs, Drugs, and Cosmetics, ensuring compliance with MDR-2017, Drug & Cosmetics Act, and Cosmetic Rules 2020.

Key Responsibilities:

  • Medical Devices & IVDs:
  • Prepare and submit applications for Manufacturing, Import, Test, and Loan Licenses (Class A, B, C & D).
  • Manage retention, endorsement, voluntary registration, and wholesale licenses (MD-42) as per MDR-2017 (CDSCO).
  • Draft Device Master File (DMF) and Site Master File (SMF).
  • Drug Licenses:
  • Handle applications for Drug Licenses (Forms 20, 21, etc.), changes, and renewals under the Drug & Cosmetics Act, 1940.
  • Submit documents on State Drug Authority portals (XLN India).
  • Cosmetic Licenses:
  • Manage applications for Import, Manufacturing, and Loan Licenses (COS-1, COS-5, etc.) under Cosmetic Rules, 2020.
  • Ensure compliance and timely renewals.
  • Compliance & Documentation:
  • Maintain QMS documentation (ISO-13485, ISO-14971).
  • Prepare SOPs and respond to regulatory queries.
  • Stay updated on CE Certification (EU MDD/EU MDR) and relevant ISO standards.

Qualifications:

  • Master’s degree in Environmental Science, Regulatory Affairs, or a related field.
  • 1–3 years of experience in Regulatory Affairs (CDSCO, Drugs, or Cosmetics).

What We’re Looking For:

  • Strong expertise in CDSCO filings, Cosmetic Rules 2020, and regulatory submissions.
  • Proven ability to handle licenses for Medical Devices, IVDs, and Drugs.
  • Up-to-date knowledge of ISO standards and Indian MDR-2017 guidelines.
  • Excellent organizational and communication skills.

Why Join Us?

Be part of a dynamic team committed to driving regulatory excellence and compliance in the healthcare and cosmetic sectors.

Interested candidates can share their resumes at:

/8800894583

Location: Sector-60, Noida



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