Regulatory Affairs Specialist

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 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

Job Types: Full-time, Permanent

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

Benefits:

• 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