DIFRA Instrumentation , specializes in the design, manufacture and commercialization of diagnostic equipment in vestibular function, is seeking :

Regulation Affairs Manager

 

Features:

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 distributorwith all the necessary documents to help them in register our products in their countries
  • Local registration at the AFMPS and to our Notify body.

Profile:

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

Languages:

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

Production Manager

 

Features:

As Production Manager, your job is :

  • Production management and control
  • Management of order for the production
  • Management of the "Production" team
  • Service and repair
  • Responsible of the technical file with the Product Manager
  • Creating and maintaining technical manuals and documentations

Profile:

Very good knowledge in:

  • Electronic
  • Inventor (CAO)

Languages:

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

Contact:

Aline DIRIX : +32-87/89.80.80

E-mail : info@difra.be