Executive Regulatory Documentation
1 week ago
**JOB DESCRIPTION ( Regulatory Documentation)**
**.* **Coordination with medical device consultant & will be responsible for creating documentation for certification & Compliance of (MDD)93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017*
**.* **Preparation of documentation for submission to INDIAN FDA*
**(CDSCO, NEW DELHI) for medical device mfg. certificate approval.**
**.* **FDA / CE / ISO 13485 - Screening of documents, compilation of dossier & drafting of letters and justifications.*
**.* **Internal-External audit compliances.*
**.* **Liasoning with drug department.*
**.* **Coordination with various consultants for preparation of regulatory documentation.*
**.* **Implementation of ISO 13485 & MDR in all Departments.*
**. Training of all departments regarding documentation & regulations.**
**Preference given**:
**. Good Communication, MS office**
**Qualification**
**.** Graduate/Post graduate
**Job Types**: Full-time, Permanent
Pay: ₹18,000.00 - ₹25,000.00 per month
**Benefits**:
- Provident Fund
Schedule:
- Day shift
Supplemental Pay:
- Performance bonus
- Yearly bonus
Work Location: In person
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