Medical device CE marking



Contact us. We may have an opening for a medical device consultant.


  • Consult with medical device manufacturers, and assist them with the implementation of the European Medical Device Regulations;
  • Gather, create, and review technical documentation;
  • Implement ISO 13485 Quality Management Systems;
  • Conduct internal audits at the costumer’s site;
  • Stay up-to-date on changes to the European Medical Device Regulations and related standards.
  • Minimum of 5 years’ experience in the medical device industry, health care or related services;
  • Experience with Quality Management Systems for medical devices;
  • Minimum education: Bachelor’s degree in (life science) technology or biochemistry;
  • Proficiency in English and Dutch language.
  • Experience as a quality / regulatory affairs manager in the medical device industry or a similar level in a healthcare facility, a regulatory body or a healthcare authority;
  • Experience as (lead) auditor for Medical Device Regulations or quality management standards;
  • Experience with international enterprises;
  • Willingness 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;
  • An informal but professional work environment.

To apply, please submit your resume and cover letter to


(Acquisitie naar aanleiding van deze vacature wordt niet op prijs gesteld.)