Director QA/RA – Quality & Regulatory Excellence (IVD)

Permanent | Gelderland, The Netherlands

We're partnering with an international In Vitro Diagnostics (IVD) manufacturer to appoint a Director QA/RA – Quality & Regulatory Excellence.

Reporting directly to the Managing Director and sitting on the Executive Leadership Team, you'll lead the global Quality Assurance, Regulatory Affairs and Quality Control functions while helping shape the strategic direction of the business.

The Opportunity

This is far more than a compliance role.

You'll define the global Quality & Regulatory strategy, foster a culture where quality is embedded across the organisation, and partner closely with R&D, Manufacturing, Operations and Commercial teams to support innovation while maintaining the highest regulatory standards.

As a member of the Executive Leadership Team, you'll help ensure quality remains a key competitive advantage for the organisation.

Key Responsibilities

• Lead the global Quality Assurance, Regulatory Affairs and Quality Control functions
• Develop and continuously improve the Quality Management System (QMS)
• Ensure compliance with ISO 13485, EU IVDR, FDA QSR/QMSR and other applicable global regulations
• Develop regulatory strategies supporting new product introductions and international market expansion
• Lead customer, notified body and regulatory authority audits
• Oversee CAPA, risk management, complaint handling, change control and post-market surveillance
• Establish quality metrics and drive continuous improvement initiatives
• Build, mentor and develop a high-performing QA/RA/QC team
• Represent Quality as a strategic function within the Executive Leadership Team

Why Join?

This is a unique opportunity to join an organisation where:

• Quality is central to the business strategy
• Products have a direct impact on patient care worldwide
• You'll influence executive decision-making and company strategy
• Innovation and regulatory excellence go hand in hand
• You'll work in a dynamic, entrepreneurial environment with global reach

About You

We're looking for an experienced QA/RA executive who combines strong regulatory expertise with commercial awareness and inspiring leadership.

You'll bring:

• A degree in Life Sciences, Biomedical Sciences, Biotechnology, Chemistry or a related discipline
• Extensive leadership experience within Quality Assurance and Regulatory Affairs in the Medical Device or IVD industry
• Strong knowledge of ISO 13485, EU IVDR, FDA QSR/QMSR and global regulatory frameworks
• Experience working with regulatory authorities, notified bodies and international customers
• A proven track record leading audits, driving continuous improvement and developing high-performing teams
• Strategic thinking, excellent stakeholder management and strong leadership skills
• Fluency in both Dutch and English

Interested?

If you're an executive QA/RA leader looking to make a significant impact within an innovative, internationally recognised life sciences organisation, we'd love to have a confidential conversation. Please apply directly or get in touch to learn more.