Regulatory Projects Specialist -IVDR

Ede, The Netherlands

Regulatory Projects Specialist -IVDR
Ede, The Netherlands
Regulatory Affairs
Full-time

Your Role

In a team of 6 people, you will fulfill a position of Regulatory Project Specialist. It will be your challenge, together with the QA/RA team, to deliver top performance as demanded by regulations and customers.

 

As Regulatory Project Specialist you will lead the implementation of the IVD Regulation which will become effective 2022. You will develop medical device files and device labeling that fulfills this new regulation. Additionally evaluation of product performance data under the new regulation is part of your responsibilities. You will be in close contact with the notified body to ensure that products will receive a CE-mark on time.

 

Your Profile

  • Higher education or 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

 

The Company

Eurotrol is an international company that provides high specification, custom-made quality control materials for in vitro diagnostics. For more information about the company or the job visit our website at www.eurotrol.com

 

Please send your resume with cover letter by e-mail hrm@eurotrol.com, phone 0318-695777