Scientist - Pathology R&D

Agilent Technologies

Glostrup, Denmark

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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