We are Hiring Regulatory Affairs Specialist For Medical Devices (Orthopedic

Implants And Instruments)

Role & Responsibilities:

1. Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA.

2. Work On Technical Master File.

3. Work On CERs (Clinical Evaluation Report) As Per EU MDR.

4. Work on Design & Development and Risk Management Files as per EU MDR.

5. Have Knowledge About QMS (Quality Management Systems).

6. Reporting To Regulatory Authorities.

7. Conducting Internal Quality Audits.

8. Have Knowledge of European CE (MDD & MDR).

9. Have Knowledge of USFDA 510K.

Skill:

1. Documentation Handling.

2. Written & Verbal Communicate Skill.

3. Have Good Knowledge Of Computer And MS Office.

Education Qualification of Candidate: B Pharm / M Pharm / Bachelor or Master Degree in

Bio-Medical Engineering / Science Discipline with Training in Medical Devices in

Regulatory Affairs.

Experience: Medical Devices: 3-5 years (Required)

Salary Criteria: 30,000.00 - 80,000.00 per month - Depends on Interview

Benefits:

Regulatory Affairs Specialist For Medical Devices