QA/RA Director

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.

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