Job opening in HCL Technologies

HCL is looking for IVDR professionals.
Education – Biotechnology, Microbiology, and Life science Background
Experience – 1 to 6yrs
Location – Chennai, Bangalore, Hyderabad, Pune, Mumbai and NCR
Job Role

  • To review the current technical and clinical data available for the products to determine if the data could be used demonstrate compliance IVDD DIRECTIVE 98/79/EC and or the proposed new In Vitro Diagnostics Regulation (IVDR 2017/746 is a plus) with respect to elements of Annex ll (Technical Documentation).
  • Execute analytical methods for testing on a variety of test samples including raw material, in-process/finished product, stability, validation, Process Development and R&D test samples.
  • Review risk management activities/documents and ensure compliance with ISO 14971.
  • Knowledge and experience with novel molecular in vitro diagnostic assays and devices (and accessories to IVD’s) is a plus.

If you have matching experience, kindly share your resume

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