Regulatory Affairs Executive

5 days ago

Noida, India corpseed ites pvt ltd Full time

Job Description:

- CDSCO Registration for medical devices, Drug & Cosmetics as per the rules and standards.
- Draft, review, submission and archival of other regulatory submissions (Query responses, corrections fillings, miscellaneous notifications regarding post registration regulatory lifecycle management) for Indian market.
- Review of technical documents before filing on CDSCO portal.
- Proper knowledge of Medical Device Rules 2017 and other ISO standards for medical device.
- Well aware with BIS registration, ISI/FMCS registration, BEE registration, WPC approval, FDA registration, Legal Metrology registration, Pollution NOC and Waste management compliance.
- Must know to handle/manage technical queries related to CDSCO (MD, Drug & Cosmetic) registration for client.
- Working experience in documentation required for quality certification.
- Knowledge of quality certification (ISI mark) of different products as per BIS norms
- Working experience in designing various testing machines as per Indian standards.

**Salary**: ₹15,000.00 - ₹30,000.00 per month

**Benefits**:

- Cell phone reimbursement
- Health insurance
- Paid sick time
- Provident Fund

Schedule:

- Day shift

Work Location: In person

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