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QA/RA Manager

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QTC are partnered with an innovate start-up company focused within the IVD space developing solutions in molecular pathology. The business have launched new products in 2023 and are looking to grow their team by hiring a Quality and Regulatory Manager.


Eindhoven - Netherlands

40 hours per week

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QTC logo icon About your role

This is how you will make the difference

The Q&R Manager will report directly into the COO and have the following key responsibilities: Optimising and extending the QMS to incorporate manufacturing and servicing capabilities Obtain and maintain product registrations within the US and EU markets Manage all documentation related to quality processes and procedures Prepare for and lead all audits related to ISO 13485, supplier and internal Develop and maintain technical files related to regulatory compliance Be the main point of contact with notified bodies

QTC logo icon what's needed

What you bring



  • Demonstrated experience across both Quality Assurance and Regulatory Affairs
  • Experience ensuring regulatory compliance in the EU and US
  • Background working within either Medical Devices or Diagnostics
  • Affinity with technology and strong analytical skills
  • Proactive and results driven
  • Worked within a start-up or scale up environment

QTC logo icon What we offer

What's in it for you



  • Competitive basic salary with a lucrative share scheme
  • Flexible work pattern 
  • Dynamic and fast-paced environment
  • Close and tight-knit team 

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