Regulatory Affairs Executive
Job Description
We Are Hiring QA/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. Have Knowledge About QMS (Quality Management Systems).
5. Reporting To Regulatory Authorities.
6. Conducting Internal Quality Audits.
7. Responsibilities For Initiating & Closing Product Recall Process.
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
Benefits:
• Health insurance
• Provident Fund
Schedule:
• Day shift
Ability to commute/relocate:
• Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (Required)
Education:
• Bachelor's (Preferred)
Experience:
• total work: 3 years (Preferred)
Work Location: In person
Application Deadline: 25/04/2024
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Job Detail
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Job IdJD3385365
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IndustryNot mentioned
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Total Positions1
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Job Type:Contract
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationGJ, IN, India
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EducationNot mentioned
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ExperienceYear