Job description

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 Valuable 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

Experiance : 3 to 8 years

Job Types: Full time, Permanent

Job Types: Full-time, Permanent

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

Perks:
Health insurance
Leave encashment
Provident Fund

Application Question(s):
How many years of experience with ISO - 13485.
Do you have knowledge of EU MDR ?
Do you have any experience in USFDA - 510.

Education:
Bachelor's (Preferred)

Experience:
Medical Devices: 5 years (Required)

Work Location: In person

📌 Regulatory Affairs Specialist Kathwada
🏢 MJ SURGICAL
📍 Kathwada