Quality & Regulatory Affairs Specialist
Senior Quality & Regulatory Affairs Specialist
Location: Remote, Netherlands
Salary / Benefits: €75,000 + 10% Bonus
Languages: Dutch (C1+) and English
Industry: Medical Devices / IVD / Diagnostics
Looking for a senior Quality & Regulatory role where you can take real ownership across both disciplines?
Want broader European regulatory exposure while working remotely from the Netherlands?
On offer is a Senior Quality & Regulatory Affairs position within an established international diagnostics organisation, combining hands-on Quality responsibilities with European Regulatory Affairs and Economic Operator compliance.
This company is a global organisation operating across the life sciences and diagnostics sector, developing and commercialising technologies used within healthcare and laboratory environments internationally.
In this role, you will take responsibility for Quality and Regulatory activities supporting the Netherlands while contributing to wider European initiatives. You'll work across MDR and IVDR compliance, QMS improvement and Economic Operator requirements, including Importer and Distributor obligations.
The ideal candidate will already have experience within Medical Devices and/or IVDs and be comfortable operating across both Quality and Regulatory Affairs. Strong knowledge of EU MDR and/or IVDR is important, alongside fluency in Dutch and English.
This role is ideal for someone who has built a solid foundation within Q&RA and now wants greater autonomy, broader European exposure and the opportunity to become a subject matter expert in an increasingly important area of EU regulatory compliance.
The Role
Own and support Quality & Regulatory Affairs activities across the Netherlands.
Maintain and continuously improve Quality Management System processes.
Support regulatory compliance across wider European operations.
Support Importer and Distributor obligations under EU MDR 2017/745 and EU IVDR 2017/746.
Help develop and maintain sustainable Economic Operator compliance processes across Europe.
Who We're Looking For
Bachelor's degree in Life Sciences, Regulatory Affairs, Quality or a related discipline.
Professional experience within Quality and/or Regulatory Affairs in Medical Devices or IVDs.
Working knowledge of EU MDR and/or IVDR.
C1+ Dutch and fluent English, written and spoken.
Lead Auditor certification, ideally ISO 9001.
Experience working within or alongside Quality Management Systems.
Previous exposure to Economic Operator, Importer or Distributor responsibilities would be particularly valuable.
Valid driving licence and flexibility for occasional travel.
What's On Offer
Remote working from the Netherlands.
Broad remit spanning both Quality and Regulatory Affairs.
Exposure to European-level projects rather than purely local Quality activities.
Opportunity to develop specialist expertise around MDR, IVDR and Economic Operator compliance.
High level of autonomy and ownership
FAQs
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