We currently have a staffing opportunity for a medical device consultant.


  • Consult with medical device manufactures, assist with the implementation of the European Medical Device Directives requirements for all risk classifications, assisting with the compilation of technical files in order to obtain the CE-mark.
    Directives concerned: MDD, IVDD and AIMDD.
  • Assisting CEpartner4U customers with the implementation of ISO 13485 quality management systems.
  • Annual review of technical documents.
  • Internal audits at customer’s location.
  • Keep up-to-date on changes to EU-Medical Device Directives and related standards.


  • Minimum of 5 years experience in the medical device industry, healthcare or related services.
  • Experience with quality management systems
  • Minimum education: bachelor degree in (life science) technology or biochemistry
  • Proficiency in the English and Dutch language.


  • Experience as quality / regulatory affairs manager in the medical device industry or a similar level in a healthcare facility, a regulatory body or a healthcare authority.
  • (Lead) auditor for Medical Devices Directives or quality management standards is a pre.
  • International experience is a pre.
  • Prepared to travel.
  • Preferably located in Utrecht (NL) area.

We offer:

  • Substantial worldwide client base.
  • Interaction with our international team members, regulatory bodies and EU Authorities.
  • New consultancy opportunities in other emerging markets like Eastern Europe, Egypt, Asia and South America
  • Informal but professional work environment

To apply, please submit a resume and cover letter to

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