
Regulatory Affairs Executive Cdsco
2 weeks ago
**Responsibilities**:
- Maintain Daily project report.
- Handling end-to-end filing, Document upload, document preparations and device master plan preparation
- Manage customer relationships through regular communication with clients through weekly/ monthly reviews.
- Discuss operational issues and critical to quality (CTQ) delivery issues with the customer.
**Experience and Qualification**:
- BPharm/ MPharm/ BTech/ MTech/ BSC/ MSc with 3-5 years’ experience of pre-market & post market regulatory work on compliance to Medical Device Rules (MDR) 2017, Drugs & Cosmetics Act & Rules governed by Central Drug Standard Control Organization (CDSCO) & state FDA for diagnostic imaging & therapy medical devices including Software medical devices.
- Should have knowledge about Medical device regulations.
- Good communication & interpersonal skills.
**Job Types**: Full-time, Permanent
**Salary**: ₹20,000.00 - ₹40,000.00 per month
**Benefits**:
- Cell phone reimbursement
- Health insurance
- Provident Fund
Schedule:
- Day shift
Supplemental pay types:
- Performance bonus
- Yearly bonus
Ability to commute/relocate:
- Noida, Uttar Pradesh: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- CDSCO: 1 year (required)
**Speak with the employer**
+91 97736 60371
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