Senior Specialist, Quality & Regulatory Affairs (Medical Devices)

Location: Woerden, Netherlands; primarily on-site, with an eligible remote work arrangement. Travel within the Netherlands and occasional travel to other EU locations is required.

Company

hirify.global develops diagnostics and biotechnology solutions that support more precise results, improved treatment options, and better access to healthcare.

What you will do

• Perform Quality and Regulatory Affairs activities for the Netherlands site in alignment with regional priorities.
• Maintain, implement, and continuously improve Quality Management System processes and infrastructure.
• Act as a subject matter expert for Economic Operator obligations under European regulations.
• Support compliance with importer and distributor obligations under IVDR and MDR.
• Develop and maintain sustainable Economic Operator compliance processes across the European region.
• Collaborate with Country Regulatory Affairs, centers of excellence, external partners, and suppliers.

Requirements

• Bachelor’s degree in Life Sciences, Regulatory Affairs, Quality, or a related discipline.
• Experience in Quality and/or Regulatory Affairs within the medical device or IVD industry.
• Lead Auditor certification for ISO 9001.
• Working knowledge of EU regulatory frameworks, including IVDR and/or MDR.
• Fluent written and verbal English and Dutch.
• Valid driver’s license with an acceptable driving record and ability to travel.

Nice to have

• Experience with Economic Operator obligations, including importer, distributor, or authorized representative responsibilities.
• Experience working cross-functionally and with external partners or suppliers.

Culture & Benefits

• Work within a diagnostics organization focused on life sciences, biotechnology, and healthcare innovation.
• Access to comprehensive benefits, including healthcare programs and paid time off.
• Flexible remote working arrangements may be available for eligible roles.
• Work with regional and global teams supporting customers and healthcare providers across multiple markets.