Technical Scientist/System Engineer - Regulatory and Quality Management of Medical Devices

“Make a Difference in Cancer Treatment and Valorize our Optical Technologies for Tissue Sensing”

Are you passionate about making a meaningful impact in healthcare? Do you want to use your technical expertise to improve cancer treatment? The Image-Guided Surgery (IGS) research group at the Netherlands Cancer Institute – Antoni van Leeuwenhoek is specialized in optical technologies for tissue sensing, guiding surgical treatment (e.g diffuse reflectance spectroscopy, hyperspectral imaging and FLIM).  We are currently developing and implementing these technologies in clinical practice. For further widespread implementation and valorization, we are seeking an enthusiastic person with background in system engineering, biomedical engineering, technical medicine or equivalent education with interest and experience in Quality management implementation & knowledge on Regulatory affairs, preferably under the In Vitro Diagnostic Regulation (IVDR).

Your Role

You will be responsible for setting up and maintaining a Quality Management System and preparing technical documentation in line with IVDR requirements of one of our devices for optical tissue measurements. You will work closely with our research & development team and clinical team.

Key Responsibilities

Quality Management System

• Set up and maintain a QMS compliant with ISO 13485

• Develop and manage SOPs, procedures, and documentation structures

Regulatory Affairs

• Prepare and maintain IVDR-compliant technical documentation 

• Lead development of performance evaluation documentation

Risk & Compliance

• Maintain risk management documentation in line with ISO 14971

• Ensure consistency across technical, clinical, and risk documentation

• Identify gaps and proactively implement solutions

Collaboration

• Work closely with engineers, scientists, and clinicians

• Translate technical and clinical data into regulatory documentation

• Support study design for clinical and performance evaluation

• MSc or PhD in System Engineering, Biomedical Engineering, Technical Medicine, Biomedical Technology & physics, or a related field

• Affinity and experience in QA/RA within medical devices of IVD

• Knowledge of  IVDR and ISO 13485

• Excellent communication and writing skills in English

• Dutch speaking is preferred

Nice to have:

• Experience in early-stage environment

• Background in optics or imaging (e.g. spectroscopy)

Your development opportunities and employment conditions

The basis for your employment conditions is in accordance with the CLA Hospitals. You will receive from us:

• The vacancy is available immediately, fulltime/parttime and hybrid working is possible;

• A contract for 1 year, with the possibility of extension;

• A gross monthly salary between € 3.395,- and € 4.818,-, based on a 36-hour working week, in line with FWG50 and depending on your experience;

• 144 holiday hours and 57 hours of Personal Life Budget, with full-time employment;

• Annual holiday pay of 8.33% and a fixed end-of-year bonus of 8.33%;

• A travel allowance of €0.23 per km;

• Free parking at the Netherlands Cancer Institute. And with our bicycle plan and discount on public transport we also make it attractive for you to leave the car at home;

• You will join a dynamic international research group directly linked to the clinic;

• You will collaborate with scientists and clinicians with expertise in different disciplines and valorisation; 

• Opportunity to exercise during working hours at our Fit Boutiqs;

• An active staff association.

Interested?

We are curious about your talent! Will you be the one to make a difference in the world of cancer care and research? Apply now by using the apply/solliciteer button at the top of the page. Please upload your motivation letter, CV and contact information of 2 references to the application form. Ensure that your references information is attached together with your motivation letter or CV, as there is no option to submit them separately. Take note: please respond to this vacancy only via the application button, and not via email.

This vacancy is open until June 20th 2026.

For further information about the position please contact Prof. Dr. Theo Ruers ([email protected]).

For questions about the application procedure, please contact Daphne Heemskerk - Recruiter ([email protected]).