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Regulatory Coordinator



Are you committed to ensure that medical devices placed on the market are safe and effective, interested to work in a challenging regulatory environment involving interface with drug regulations, and willing to enter the regulatory field or expend your knowledge?

 Do you want to be part of a team responsible for the development, registration and post-market activities related to combination products worldwide?

 Then you may be the person we are looking for to join our growing team in Phillips-Medisize’s Global Innovation & Development Center based in Virum and Struer.

What You Will Do In Your Role

As a Regulatory Coordinator you will

  • Support the regulatory team in the following regulatory activities related to registration:
  • Contracting, managing, and reporting in relation to in-country representatives.
  • Recording and keeping track of costs & timeline for registration based collected data.
  • Handling translation and authentication of regulatory statements and certificates.
  • Handling practicalities related to technical document submission.
  • Archiving documentation related to interaction and approval from Heath Authorities.
  • Keeping Regulatory Information Management Platform up to date.
  • Capture and process lessons learned for each performed submission.

 Support the regulatory team in the following activities related to processes and projects:

  • Update procedures and templates to include requirements related to new countries.
  • Update procedures and templates to reflect changes in the regulatory environment.
  • Review projects’ regulatory documentation to support projects, if required.
  • Author projects’ regulatory documentation to support projects, if required.

The Experience You Will Bring


  • Bachelor’s degree, either science, biomedical or engineering is preferred
  • Systematic, rigorous, and structured thinking and documentation.
  • Strong collaboration and organizational skills, and the ability for multi-tasking.
  • Pro-activity, self-drive and commitment to process improvement.
  • Ability to work in an evolving, challenging, and multi-disciplinary environment.
  • Excellent written and verbal communication skills in English.
  • Proficiency with MS Office.

What Will Put You Ahead

  • Experience in a similar position
  • Knowledge of the regulatory environments for medical devices


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