Vacancy Regulatory Affairs Officer – Amsterdam


Organization

At this moment, we are working together with an innovative spin-off that focuses on Medical Diagnostics with a specialisation in the treatment of cervical cancer and (pre)cancers. We contribute to improving patient health and health programs worldwide. We have an open position as a Regulatory Affairs Officer. Within this role you will have the opportunity to develop yourself in the field of Regulatory Affairs and you will make a major impact on the success of this organisation with a versatile position.


Function

You will be preparing and updating technical files for ISO 13485, IVDR and executing the transition from IVDD to IVDR. This position is a great opportunity to apply your expertise, build and advance your knowledge. The main responsibilities are:

  • The transition from IVDD to IVDR for commercial registration of our partner’s test portfolio
  • Registration of tests with regulatory partners
  • Filing, updating and communication with notified bodies
  • Collaboration with the scientific R&D team on new or expanded claims
  • Quality assurance
  • Certification and audits
  • Regulatory Affairs
  • Support of clinical studies and test development performed by the R&D department

Requirements

The ideal candidate profile looks the following:

  • Experience in regulatory, performance evaluation in the IVD sector, ISO and quality assurance is preferred
  • A technical or scientific degree (MSc or PhD) in molecular biology, oncology, biomedical sciences, or other relevant studies
  • Preferably at least one year of work experience, specifically in IVDR through industry, advisory or regulatory (notified bodies) roles in manufacturing, R&D, quality or regulatory roles. Candidates without specific experience but with a passion for regulation and in vitro diagnostics are also invited to apply. Experience in the IVDR industry, advisory or regulatory is an advantage but not necessary
  • Good knowledge of IVD regulations or willingness to develop this knowledge
  • Experience with ISO 13485 quality systems; Audit experience is a plus but not necessary
  • Ability to manage and monitor moderately complex projects in close collaboration with our dedicated R&D team
  • Project management skills

Offer

  • Job Type: Fulltime
  • Salary: €2,500 – €3,700 depending on experience
  • 25 holidays
  • Our partner has highly experienced external advisors to support the Regulatory Affairs Officer to gain knowledge and experience and grow within the company

Application

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

Yusuf Noori
Associate | Medical Devices

+31(0)6-82 06 83 15
+31 23 754 86 60
y.noori@qtcrecruitment.com