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Job ID :
49236BR
Location :
Germany - Freiburg
:
Job Description
Location: Freiburg
Job-ID: 49236BR


We are the leading supplier of fully automatic blood analysis systems for allergy and auto-immune diseases. With our innovative products, we set standards worldwide and assist clinicians in providing fast and reliable diagnoses, thus helping patients at an early stage. Phadia GmbH in Freiburg is the German subsidiary of the Immunodiagnostics division of Thermo Fisher Scientific, a global company that develops, manufactures and distributes in vitro diagnostics in the field of allergy and autoimmune diagnostics. Our customers expect a consistently reliable and high standard of quality from our products, which we ensure through innovative biochemical and medical technology solutions as well as highly qualified and motivated employees.



Essential Job Functions and Accountabilities
  • Actively participate in product registration projects on defined global markets
  • Compile and submit required documentation to obtain registration licenses
  • Communicate with internal and external partners and with regulatory authorities in specified countries
  • Participate in product development as regulatory expert
  • Participate in the vigilance process
  • Proactively provide regulatory requirements and communicate clear regulatory strategies for development projects
  • Review and approve product documentation
  • Contribute to improved routines and processes for the Global Regulatory Affairs team



Qualifications
  • University degree in natural or pharmaceutical science, knowledge in Immunology is of advantage
  • 3+ years experience in global IVD product registration is a plus
  • Experience from US, Asian, East European and/or South American countries is a plus.
  • Practical experience in Quality Management (esp. ISO 13485) is of advantage
  • Fluent in English and German, both spoken and written
  • Independent and well-structured approach of tasks
  • Excellent team working and communication skills
  • Positive attitude and service-minded


We offer
  • Employment with an innovative, growth-oriented organization
  • Outstanding career and development prospects
  • Company pension scheme and other fringe benefits
  • Exciting company culture which stands for integrity, intensity, involvement and innovation
*IND-EMEA

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