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QA/RA Specialist – Medical Devices

Job Summary (0.8 – 1.0 FTE):

As a Quality Assurance (QA) and Regulatory Affairs (RA) Specialist, you will play a key role in implementing and maintaining our ISO 13485 Quality Management System and preparing the Technical Documentation required for CE marking and FDA submissions. You will work closely with R&D, software, and clinical teams to ensure our documentation is complete, consistent, and compliant as we scale our product toward market release. This role is perfect for someone who thrives in a startup environment, enjoys building processes, and wants to contribute directly to bringing an innovative medical device to market.

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Key responsibilities:

  • Support implementation, maintenance, and continuous improvement of the ISO 13485 QMS

  • Prepare, write, review, and organize Technical Documentation (EU MDR, FDA)

  • Contribute to creation and rollout of QMS processes and workflows

  • Collaborate with R&D, software, and clinical teams to ensure traceability and documentation consistency

  • Support risk management activities (ISO 14971), document control, DHF creation, and change control

  • Assist with internal audit preparation and regulatory readiness

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​​Qualifications and Skills:

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

  • Experience with medical device regulations (EU MDR, FDA) and ISO 13485

  • Strong technical writing and documentation skills

  • Structured, proactive, and comfortable in a startup environment

  • 2+ years of relevant experience preferred

  • Experience with software-based QMS tools (e.g., Greenlight Guru, Qualio, MasterControl) is a plus

  • Familiarity with SaMD is a plus

  • Ability to join in-office meetings in Ede at least once a week

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What we offer:

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  • Competitive salary and benefits with a healthy work–life balance

  • A meaningful opportunity to bring innovative neurotechnology to real-world clinical use

  • A collaborative, ambitious, and supportive startup team

  • Freedom to grow your skills and shape processes from the ground up

  • Flexible at-home and in-office working arrangements and travel allowance
     

More information:

For more questions on the position please feel free to contact careers@mindaffect.nl.

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