ID EXISTS
POS 2776
Status 7
DJM 1

MDR Technical Writer

Beschreibung: For one of our German Medtech clients we are seeking freelance support as: MDR Technical Writer (M/F)
Tasks:
  • Prepare MDR technical file using pre-existing MDD technical file
  • Technical writing to fill in gaps
  • Work with team members to identify needed updates to technical file and test reports/labelling.
  • Complete EU technical files, support US FDA submissions and deficiency responses
  • Support Regulatory Affairs Department concerning product developments
Qualification:
  • Start: asap, latest March 2019 / 1 years duration / 3-4 days per week
  • Completed college degree, preferable engineering or life sciences background
  • Best to have MDD experience, class II and Class III
  • Nice to have is cardiovascular product experience and FDA 510(k) experience
  • Business fluency in English, nice to have German
Bemerkungen: WANTED: MDR Technical Writer (M/F). +49 89 18 90 998 34 or Thomas.Wieczorek@k-recruiting.com Skills: English, German, MDR / MDD (Medical Device Directive / 93/42 EEC), Medical Devices, Technical Documentation & Writing / DHF (Design History File)

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