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Regulation Affairs Manager - Belgium  

Difra (company)


Posted on : 10 August 2017

Project Description

Regulation Affairs Manager
As responsible of Regulations Affairs, your job is :
  • Maintaining ISO 13485 Quality system 
  • Internal Audit 
  • Responsible of the product quality 
  • Responsible of the technical file 
  • Creating and maintaining technical manuals and documentations 
  • Support our distributor with all the necessary documents to help them in register our products in their countries 
  • Local registration at the AFMPS and to our Notify body. 

Very good knowledge in:
  • Quality management ISO 13485 
  • Medical Device Directive 93/42 
  • Basics in electronics to be able to analyze and verify technical documents or technical file 

  • French (native) 
  • English (Professional) 
  • Dutch (Optional)