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QA/RA Manager
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.
Details
Eindhoven - Netherlands
40 hours per week
Get to know
Your consultant
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
what's needed
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 we offer
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
Send your application