Clinical Affairs Scientist (M/F)

 

Your responsibilities:

  • Organize, maintain and expand internal and external clinical performance evaluation studies with clinical investigators
  • Develop and maintain relationships with Key Opinion Leaders
  • Obtain necessary clinical sample material for development and manage product verification studies
  • Ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications
  • Project Management and action as interim person between different departments
  • Develop and sustain Post-Market-Surveillance-system
  • Risk management
  • Develop relevant documentation (SOP, process instructions, instructions for use, performance evaluation reports, etc…)
  • Ensure adherence to protocols and compliance with guidelines and regulations (IVDR, IVDD, ICH, GHTF, FDA, …)
  • Compile and review performance evaluation reports, educational material for users, marketing material, etc…
  • Develop educational articles/news
  • Search for brand related publications

Your profile:

  • Minimum BA/BS in scientific discipline
  • Experience in Clinical Affairs at an IVD or medical device manufacturer/supplier
  • Good knowledge of ISO 13485 quality system requirements
  • Knowledge of IVD regulation (devices of class C and D) and IVD directive (devices of Annex II, list A)
  • Knowledge of 21 CFR 820 is considered as an advantage
  • Enthusiasm to work in an international team within a highly collaborative environment
  • Fluency in written and spoken English is essential. Any other European language is an advantage

 

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