Device Engineer

5 days ago


Thrissur, India Sofomation Full time

OPENING FOR A WELL KNOWN OIL AND GAS COMPANY In MIDDLE EAST:

Position: IVDR Assessor

Experience:

  • 4+ years of industry experience in IVD devices (design, testing, manufacturing, or regulatory).
  • Minimum 2 years in hands-on product work or as an assessor/auditor.


Minimum Requirement:

  • Degree in a relevant field: Biology, Microbiology, Biochemistry, Biotechnology, Pharmacy, Medicine, etc.
  • 4+ years of industry experience in IVD devices (design, testing, manufacturing, or regulatory).
  • Minimum 2 years in hands-on product work or as an assessor/auditor.
  • Strong knowledge of IVDR, ISO 13485, ISO 14971, and harmonized standards.
  • Prior Notified Body or regulatory audit experience is highly desirable.
  • Excellent communication, analytical, and technical writing skills



**Interested Candidates Can Apply Or Share Your Updated CV on gautam@sofomation.com**



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