- 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
- 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
- An exciting and diverse work environment with many challenging tasks
- A chance to be part of the lifecycle support of state-of-the art IHC, ISH and primary stains products to the benefit of cancer patients, world wide
- Great colleagues and a strong team spirit
- Many opportunities for personal career and expertise development
- Competitive salary and benefits Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.
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R&D Scientist - Glostrup, Danmark - Agilent
Beskrivelse
Description
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek ---- so they can do what they do best: improve the world around us. Information about Agilent is available at
Will you join us in the fight against cancer?
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:
You will be based in our offices in Glostrup, Denmark, in an exciting work environment within a dynamic function of 67 people. The function consists of 5 departments responsible for Future Assay Technologies, Product Development, Launch, Product Lifecycle Management and Histopathology support.
Qualifications
What we offer:
Travel Required
NoSchedule
Schedule:Full timeShift
DayDuration
Over 12 MonthsJob Function
R&D