Senior Specialist, Quality & Regulatory Affairs
Location: Netherlands (Remote/Hybrid)
Industry: Medical Devices / Diagnostics / Life Sciences
Language Requirement: Fluent Dutch & English
About the Opportunity
Our client is a globally recognised leader within the life sciences, diagnostics, and healthcare technology sector. With a strong focus on innovation, quality, and compliance, they are seeking a Senior Specialist, Quality & Regulatory Affairs to support Quality and Regulatory activities across the Netherlands and broader European operations.
This is an excellent opportunity for a quality and regulatory professional looking to take ownership of compliance activities within a highly regulated environment while working with a diverse international stakeholder network.
Key Responsibilities
- Support Quality & Regulatory Affairs activities across the Netherlands and Europe.
- Maintain, enhance, and continuously improve Quality Management System (QMS) processes.
- Act as a Subject Matter Expert for MDR and IVDR Economic Operator requirements.
- Provide guidance on importer and distributor compliance obligations.
- Support internal, supplier, and external audits.
- Drive CAPA investigations and quality improvement initiatives.
- Partner with Regulatory Affairs and Quality stakeholders across multiple European markets.
- Support regulatory inspections and organisational audit readiness.
- Contribute to the development and maintenance of quality and compliance procedures.
Requirements
- Bachelor's degree in Life Sciences, Quality, Regulatory Affairs, Biomedical Sciences, or a related field.
- Previous experience within Medical Devices, Diagnostics, IVD, or other regulated healthcare industries.
- Strong knowledge of MDR and/or IVDR regulations.
- Experience with Quality Management Systems (QMS), CAPA processes, and regulatory compliance activities.
- ISO 9001 and/or ISO 13485 auditing experience.
- Fluent Dutch and English, both written and spoken.
- Strong stakeholder management and communication skills.
- Ability to work independently while collaborating across international teams.
What's on Offer
- Opportunity to join a market-leading international healthcare organisation.
- Exposure to complex European Quality & Regulatory Affairs activities.
- Broad stakeholder engagement across Quality, Regulatory, Operations, and Commercial functions.
- A highly collaborative and quality-driven culture.
- Excellent long-term career development opportunities within a growing global business.
If you are a Dutch-speaking Quality & Regulatory professional with experience in MDR, IVDR, audits, and quality systems, we would be interested in speaking with you confidentially.
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