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Job Summary (0.8 – 1.0 FTE):

Do you have an interest in being at the forefront of innovation for patient care? Do you have an affinity for medical technology? Do you want to be part of the next generation of neurotechnological products to diagnose sensory pathways? Then you might be MindAffect’s new certification specialist in medical devices.

What you can expect from this role:

As our Certification specialist you will take ownership of the regulatory strategy and its implementation at MindAffect. This is a critical role to the company's future. For this position, knowledge on the European Medical Device Regulation (MDR) and US FDA certification Process for Class 2a medical devices is required.


Your main task will include:

  • Develop and execute the global regulatory strategy of MindAffect working closely with the senior management team

  • Lead the implementation of our medical device certification process and oversee the continuous compliance for medical software in the EU (MDR) with the senior management and a professional certification advisory firm

  • Develop and maintain internal procedures to ensure compliance to MDR as well other medical device regulations and standards

  • Gather, structure, and formalize relevant information in order to fulfill regulatory requirements

  • Create, implement, and document processes together with internal cross-functional teams like Engineering,

  • Product development, R&D, and Management team

  • Promote awareness of the MDR throughout the organization through regular training/briefing sessions

  • Monitor and communicate progress of the MDR project to ensure compliance with internal quality objectives

  • Guide product reviewers and other clinical experts in the assessment of the clinical evaluation


Where you will work:

The job can be mostly performed remotely. However, it is required that we meet at the office once a week. The office is located in Ede, Netherlands. Our growing team currently consists of 9 international R&D engineers and software specialists who are highly enthusiastic and committed professionals.

Qualifications and Skills:

  • Bachelor/Masters Degree (HBO or University) in a clinical or technical field

  • Experience with Medical Certification Process

  • Good organizational and people management skills

  • You work in a structured manner and pay attention to quality and details

  • You are a strong communicator, both orally and in writing

  • Extensive knowledge of Word, Excel, and Powerpoint

  • Excellent command of English and good command of the Dutch language

  • Knowledge in basic neuroscience and/or brain imaging and/or the hearing/vision medical field is a bonus


What we offer:

  • Competitive salary and benefits

  • Good work-life balance is important to us

  • A chance to be a part of bringing exciting technology out of the lab and into the real world for the benefit of over 2 billion people worldwide

  • Working in an inspiring start-up mentality team with ambitious and driven professionals in the field

  • Opportunity to expand your knowledge and learn skills that interest you

  • Travel allowance


More information:

For more questions on the position please feel free to contact

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