Regulatory Affairs Scientist (M/F)

 

Your responsibilities:

  • Work as a member in the Clinical and regulatory affairs department
  • Support the Clinical and regulatory affairs team in the tasks of generating and updating all relevant documentation (SOP, process instructions, manuals, ...) according to the ISO 13485-2016 and the applicable regulatory requirements
  • Assist  preparation of  the necessary documents for registration purpose based on regional regulatory legislations and guidance
  • Assist the team in establishing and maintaining technical files
  • Plan projects and act as an interim person between different departments

Your profile: 

  • BS/BA in scientific discipline (Life Science/ Biology) /advanced degree where required or equivalent combination of education and experience
  • Experience in Regulatory Affairs at a medical device manufacturer or supplier
  • Good knowledge of EU (ISO 13485) quality system requirements
  • Knowledge of new IVDR and US (21 CFR 820) is considered an advantage
  • Driven individual with a history of developing collaborative, cross-functional solutions
  • Highly developed writing and interpersonal skills with the ability to work on diverse teams
  • Working knowledge of common computer software applications (WORD, EXCEL, Adobe Acrobat, etc.)
  • Strong focus attention to details
  • Fluency in written and spoken English, any other language is consider as an asset
  • Excellent interpersonal and organizational skills

 

The position will be based in Luxembourg.

 

If you feel that our job profile matches your qualifications and personality, please do not hesitate and send us your application in English, including CV, covering letter and your expected salary, by post or email to the following address:

 

Fast Track Diagnostics S.à.r.l.

Ms. Elisabeth CHACTOURA

29, rue Henri Koch- L-4354/ Esch s/ Alzette

e-mail: Elisabeth.Chactoura@fast-trackdiagnostics.com