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
- 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 email@example.com.