JOB DESCRIPTION

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).

2. Work On Technical Master File.

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

4. Work on Risk Management as per EU MDR

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

6. Reporting To Regulatory Authorities.

7. Conducting Internal Quality Audits.

8. Have Experience Or Knowledge Of European CE (MDD & MDR).

9. Have Knowledge Of USFDA 510K.

Skill:

1. Documentation Handling

2. Written & Verbal Communicate Skill

3. Have Positive 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

Job Types: Full-time, Permanent

Benefits:

Health insurance

Leave encashment

Provident Fund

Pay: ₹40,000.00 - ₹70,000.00 per month

Benefits:

- Leave encashment
- Provident Fund

Work Location: In person

📌 Regulatory Affairs Specialist (Kathwada)
🏢 MJ SURGICAL
📍 Kathwada