Regulatory Affairs Executive

2 weeks ago


Ahmedabad Gujarat, India MJ SURGICAL Full time

We are Hiring Regulatory Affairs Specialist for Medical Devices (Orthopedic Implants and Instruments)

Role & Responsibilities:
1. Documents preparation for ISO13485, CE Certificate (EU MDR), USFDA.
2. Work on technical master file.
3. Work on CERs (clinical evaluation report)
4. Have knowledge about QMS (quality management systems).
5. Reporting to regulatory authorities.
6. Conducting internal quality audits.
7. Responsibilities for initiating & closing product recall Process.

Skill:
1. Documentation handling
2. Written & verbal Communicate skill
3. Have good knowledge of computer and MS Office.

B Pharm / M Pharm / Bachelor or Master Degree in Bio-Medical Engineering / Science discipline with training in medical devices in Regulatory Affairs

Experience: Minimum 3years in same post

**Salary**: Based on experience

Job Location: Kathwada GIDC, Ahmedabad

**Salary**: ₹15,000.00 - ₹70,000.00 per month

Schedule:

- Day shift

**Experience**:

- total work: 3 years (preferred)



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