Executive Regulatory Documentation

1 week ago


Roorkee, India PYRAX POLYMARS Full time

**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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