QA/ RA Specialist (Medical Devices)

QA/RA Specialist – Medical Devices

Help bring a breakthrough brain driven hearing test to the world

 

Work Model: Mainly remote, but at least one day per week in the office is required
Location: Ede, Netherlands
Commitment: 80% to 100% FTE
Start Date: As soon as possible
Eligibility to Work: EU citizenship or valid EU work permit required

About the Venture

MindAffect is a Dutch health tech company that has created a revolution in hearing assessment. Instead of relying on subjective “press the button when you hear this” tests, our technology reads how the brain responds to sound in real time at 6 times the standard rate of existing brain response based hearing tests. This makes hearing assessments faster, more reliable and accessible to people of all ages and abilities.

Our innovation is a portable device that combines audio stimulation and EEG brain response measurement in one perfectly synchronized system. This is the first device of its kind globally. It is easy to use, does not require highly trained specialists and has the potential to bring high quality rapid hearing testing into clinics, retail stores, schools, community centers and underserved regions around the world.

After winning the Innovation Prize at the World Congress of Audiology, validating our system with partners such as Horzentrum (University of Oldenburg) GN Resound and Specsavers and securing significant grants, we are now preparing the device for CE marking and clinical rollout. This is a pivotal and exciting moment for MindAffect and we are looking for a QA RA Specialist who wants to help bring this breakthrough to market.

Purpose of the Role

As our QA/RA Specialist you will play a central role in turning our validated system into a fully certified Class 2a medical device. You will take ownership of critical quality and regulatory activities, accelerate the creation and organization of technical documentation and ensure we meet all requirements for market approval and clinical deployment.

This is a hands-on role for someone who wants to see their QA RA expertise translate into meaningful progress and real world impact.

Key Responsibilities

Quality and Regulatory Execution

• Implement and continuously improve our ISO 13485 QMS
• Prepare, write and review Technical Documentation for EU MDR submission

Technical Documentation and Risk Management

• Lead risk management activities (ISO 14971), usability engineering, document control and DHF creation
• Ensure complete traceability and documentation integrity across engineering, software and clinical teams

Regulatory Readiness

• Support internal audits, certification readiness and notified body interactions
• Help prepare for compliance testing and upcoming clinical investigations

Cross Functional Collaboration

• Work closely with R and D, neuroscience, software and clinical teams to move documentation and processes forward efficiently
• Bring structure, clarity and momentum to complex and fast moving work

What You Bring

Must Have

• 3 to 4 or more years of experience in QA and or RA for medical devices, including experience with software based devices or combined hardware software systems
• Solid understanding of EU MDR, ISO 13485 and ISO 14971
• Strong technical writing and documentation skills
• A proactive and solutions oriented mindset, comfortable balancing quality with practical timelines
• Eligibility to work in the EU and ability to be in the office in Ede once per week
  
  

Nice to Have

• Experience with FDA pathways
• Startup or scale up experience
• Familiarity with QMS tools such as Greenlight Guru, Qualio or MasterControl
• Academic or professional background in biomedical engineering, neuroscience or related fields
  
  

What We Offer

• Competitive salary and equity options based on milestone achievements
• A rare opportunity to bring a first in the world neurotechnology to clinical reality
• A collaborative, ambitious and supportive team
• Flexible hybrid working and a non hierarchical culture
• Opportunities for professional growth, conference participation and shaping processes from the ground up
• The satisfaction of contributing to better hearing diagnostics for millions of people around the world

About NLC Health Ventures

NLC Health Ventures is a leading healthtech and biotech innovation platform based in Amsterdam, combining venture building and fund management across Europe and North America. With 40-45 employees, NLC manages four captive funds investing in ventures from pre-seed to Series B-C, and is fundraising for a fifth fund. The funds have a diverse LP base and are invested in over 70 companies. NLC values a collaborative, open, and impact-driven culture, where team members’ ideas and contributions truly matter.