R&D Scientist - Pathology

R&D Scientist - Pathology

Agilent Technologies

Glostrup, Denmark

We are hiring R&D Scientists for a temporary period of 24 Months in R&D Assay Development, to join us in the lifecycle support of state-of-the art in vitro diagnostic devices to the benefit of patients throughout the world.

Your primary role will be to support the registration of our Pathology products according to the European Regulation on In Vitro Diagnostic Medical Devices (IVDR). This includes getting the technical documentation in compliance with IVDR requirements within areas such as scientific validity, analytical and clinical performance and device description.

Your tasks will include

  • Active participation in implementation of strategy to ensure compliance with IVDR requirements across the entire product portfolio;
  • Support registration of the Pathology products according to IVDR regulation;
  • Design history file (DHF) update and maintenance;
  • Design control such as risk management;
  • Stakeholder management/communication (internal);
  • Participation in audits of Pathology products.

Qualifications

  • Master’s in a Life Science discipline (Chemistry, Biology, Biochemistry, Biotechnology or similar);
  • Knowledge of IHC (Immunohistochemistry);
  • Experience with Design Control, Risk Management, Usability Engineering, Product Development or Manufacturing around Medical/Diagnostics devices is an advantage;
  • Full fluency in English. Note that fluency in Danish is not required;
  • Knowledge of ISH, Primary stains or special stains and Cancer is a plus;
  • On a personal level, you are a reliable, proactive, positive and outgoing individual.

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