Technical File Specialist - Amsterdam

Vacancy information

Publication date:January 08 2021
Employment type: Permanent
Sector: Biotechnical
Function Group: Quality/RA

Function Group: Quality/RA / RA Officer

Organization

For one of the market leaders in the IVD that is growing rapidly we are looking for a Technical File Specialist. The organisation located in Amsterdam plays a role in cancer diagnostics with a focus on the improvement of patient lives.

Function

Currently the organisation is undergoing the transition to the EU IVDR and technical files play a huge role in this proces. In this role you are part of a driven team with task that included but not limited to making sure al files are compliant. You also improve the process of updating and maintaining these files, review labeling and ensure files are suitable for submission to EU IVDR Eudamed Database and support regulatory affairs in this submission.

Requirements

The ideal candidate has:

  • A Master/Bachelor degree
  • Experience with technical writing and regulatory (or quality) in biotechnology / medical devices / pharmaceuticals
  • Experience in working according Good Documentation Practices
  • Fluent in English
  • Excellent communication skills
  • Able to work independently

Offer

The organisation has the following to offer:

  • A market competitive salary
  • 3% bonus
  • A good pension scheme
  • 26 vacation days

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Quintes Hamer
Associate | Medical Devices

+31(0)6-82100758
+31(0)23-7548660
q.hamer@qtcrecruitment.com

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