Jobid: 3195970006 (0.11)
Overview
In this role you will support Quality & Regulatory compliance for the Netherlands and broader Europe, focusing on Economic Operator obligations under EU law. You will maintain and improve QMS processes to back the Commercial organization, and serve as an SME for EO requirements across Europe, with initial emphasis on IVDR and MDR. The role involves collaborating with regulatory and COE teams to ensure importer/distributor obligations are met and EO processes are sustainable. You will be part of a global diagnostics team that accelerates innovation and improves patient outcomes.
Arbeidsvoorwaarden / Benefits
- remote work arrangement eligible
- healthcare program
- paid time off
Verantwoordelijkheden
- Support general Q&RA activities for the Netherlands site aligned with the COE and regional priorities
- Maintain, implement, and continuously improve QMS processes to ensure compliant operations
- Act as Q&RA SME for Economic Operator obligations across European regulations (IVDR, MDR)
- Support compliance with importer and distributor obligations (Articles 13 & 14 IVDR/MDR) in collaboration with Country Regulatory Affairs and COE functions
- Develop, implement, and sustain EO compliance processes across the region
Belangrijkste vereisten
- Bachelor’s degree in Life Sciences, Regulatory Affairs, Quality, or related discipline
- Experience in Quality and/or Regulatory Affairs within 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)
- Willingness to travel within the Netherlands and to other EU locations
- Valid driver’s license with acceptable driving record
- Cross-functional collaboration
- Attention to detail
- Effective communication
- EU regulatory frameworks knowledge (IVDR/MDR)
- Quality Management System (QMS) maintenance
- Lead auditor ISO 9001
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