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Regulatory Affairs Manager (m/f)

  • 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
  • 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

—> Job description

Thermo Fisher Scientific
79111 Freiburg