Senior Specialist, Quality & Regulatory Affairs
On-siteAmsterdam, North Holland, The Netherlands or Utrecht, Utrecht, The Netherlands
Job Summary
Perform general Quality and Regulatory Affairs activities for the Netherlands site, aligned with regional priorities. Maintain, implement, and continuously improve Quality Management System processes to ensure best-in-class compliance. Act as a subject matter expert for Economic Operator obligations under EU legislation, with emphasis on IVDR and MDR regulations. Support compliance with Importer and Distributor obligations in collaboration with Country Regulatory Affairs functions. Maintain sustainable EO compliance processes across the region. This on-site role in Woerden supports the Commercial organization's quality infrastructure, reporting to the Quality and Regulatory Affairs Manager. Fluency in English and Dutch is required.
Required Qualifications
- Bachelor's degree in Life Sciences, Regulatory Affairs, Quality, or related discipline
- Experience in Quality and/or Regulatory Affairs within the Medical Device and/or IVD industry
- Lead auditor certification (ISO 9001)
- Working knowledge of EU regulatory frameworks, including IVDR and/or MDR
- Fluent in English and Dutch (written and verbal)
- Ability to travel – including within the Netherlands and occasional travel to other EU locations
- Must have a valid driver's license with an acceptable driving record
Desired Qualifications
- Supporting or interacting with Economic Operator obligations (Importer, Distributor, AR, or equivalent roles)
- Experience working cross‐functionally and with external partners or suppliers
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