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QA/RA Manager Eindhoven • QTC Recruitment
Gevraagd
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40 uur
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Engels (taal)
Aanbod
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Vast contract
Vacature in het kort
Eindhoven
Join a dynamic start-up in the IVD space as a Quality and Regulatory Manager. You'll work closely with the COO, optimizing the QMS and managing product registrations in the US and EU. Be the main point of contact for audits and maintain technical files. Enjoy a competitive salary with a lucrative share scheme, flexible work patterns, and a fast-paced environment. Become part of a close-knit team and make a real impact in the field of molecular pathology. Continue reading to discover why this job might be perfect for you.
Over het bedrijf
QTC Recruitment
Volledige vacaturetekst
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.
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
What you bring
Requirements:
- 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
What's in it for you
Offer:
- Competitive basic salary with a lucrative share scheme
- Flexible work pattern
- Dynamic and fast-paced environment
- Close and tight-knit team
Gerelateerde zoekopdrachten
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