Regulatory Affairs Officer

3 weeks ago

Daman, India Naman Staffing Full time

**Job Description**:
**Job Details**

**Position **:QA - Regulatory Affairs Officer/ Executive

**Job Location **:Daman

**About the company**:
One of the leading names in the manufacturing of, medical devices, customized machines, tooling, robotics and automation services.

**Job Requirement**:
B.sc/M.sc/B.E Chemical/M. Tech/ B. Pharm/ M. Pharm with Min. 2 years of Experience in Regulatory Department

**Job Role**:

- Should have working experience on ISO 13485, FDA 510k,
- CE Marking processing for medical devices,
- Medical devices, knowledge on MDR, Technical File requirements, cable handling various regulatory requirements,
- Represent RA in notified body audits (ISO 13485), knowledge of CTD requirement for devices
- Create and maintain product technical file
- Reporting to regulatory authorities

**Contact Person **:Mital Nakhate

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