QA/RA Officer - Medical Devices

Ede, The Netherlands

QA/RA Officer - Medical Devices
Ede, The Netherlands
Regulatory Affairs

Your Role
In a team of 6 people, you will fulfill a position of QA Officer (70%) as well as of RA Officer (30%). It will be your challenge, together with the QA/RA team, to deliver top performance as demanded by regulations and customers.

As Quality Assurance Officer you will be responsible for

  • timely assessment of customer complaints and coordinate investigations
  • document control and coordinate the training process
  • Improvement of the complaint and document control processes

As Regulatory Affairs Officer you are in close contact with OEM manufacturers, local distributors and competent authorities worldwide. You will register new In-Vitro Diagnostic medical devices and support OEM manufacturers and local distributors with registrations.

Your Profile

  • HBO / Academic degree
  • Enthusiastic, highly motivated, self-disciplined and well-organized
  • Results oriented and eager to learn
  • Customer-focused and process-oriented
  • Strong oral and written communication skills in English and Dutch
  • Preferably knowledge of compliance requirements and quality guidelines
  • Preferably relevant work experience (1-3 years)

Why Should You Apply?

  • A position in a healthy organization with a promising future
  • Personal development through guidance, education and knowledge sharing
  • A competence development model focused on your personal ambitions
  • Support in creating safer healthcare
  • Able to leave your mark on the job
  • A market-competitive salary and dynamic work environment