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#123592
Diegem
Fulltime
30-04-2021
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RA Specialist

As our Regulatory Affairs Specialist, you will be responsible for:

  • Review and analysis of guidelines
  • Registration of documents
  • Assisting the business units with the launch of new CE-marked medical devices
  • Maintaining knowledge of medical device regulations in EU member states to ensure the requirements are current and up-to-date. You ensure that information on regulations and requirements, especially those that are new or changed, is disseminated within the company
  • Supporting the quality management systems
  • Providing training of personnel on mandatory quality system procedures when necessary to ensure compliance with legal requirements
  • Reporting to the management team


Wat wij van jou vragen:

  • Language skills: English - any additional language is a plus
  • Knowledge MS-Office & SAP
  • Studies: studies in this field are a must (technical / scientific)
  • Knowledge and 2-3 years of experience of EU CE marking / regulatory affairs is required


Wat wij jou bieden:

  • Full-time assignment, option permanent
  • Competitive salary including meal vouchers, hospitalisation insurance, group insurance,...
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