We Are Hiring Regulatory Affairs Specialist For Medical Devices (Orthopedic Implants And Instruments)

*Role & Responsibilities:

- Documents Preparation For ISO13485, CE Certificate (As Per EU MDR).
- Work On Technical Master File.
- Work On CERs (Clinical Evaluation Report) As Per EU MDR.
- Work on Risk Management as per EU MDR
- Have Knowledge About QMS (Quality Management Systems).
- Reporting To Regulatory Authorities.
- Conducting Internal Quality Audits.
- Have Experience Or Knowledge Of European CE (MDD & MDR).
- Have Knowledge Of USFDA 510K.

Skill

- Documentation Handling
- Written & Verbal Communicate Skill
- 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

Job Types: Full-time, Permanent

Benefits

Health insurance

Leave encashment

Provident Fund

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

Advantages

- Leave encashment
- Provident Fund

Work Location: In person

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