Manager-Regulatory Affairs
4 weeks ago
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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