Regulatory Affairs Scientist (M/F)

 

Your responsibilities: 

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

Your profile: 

  • Minimum BA/BS in scientific discipline
  • 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