Global Director QA/RA & PRRC - Quality & Regulatory Excellence
(In Vitro Diagnostics)
Member of the Executive Leadership Team | Reporting directly to the Managing Director
Quality isn’t part of our business.
It is our business.
Every day, millions of patient test results depend on diagnostic systems performing exactly as intended.
Before laboratories can trust those systems, they must first trust their quality controls.
That confidence starts with Eurotrol.
For more than 30 years, Eurotrol has developed and manufactured highly specialized quality control materials for In Vitro Diagnostics. Our CueSee® solutions help hospitals, laboratories, point-of-care sites, proficiency testing organizations and leading IVD companies verify diagnostic performance in more than 100 countries worldwide.
We don’t simply manage quality.
We deliver it.
As we continue to expand globally and develop increasingly advanced quality control solutions, we are looking for an exceptional leader to shape the future of Quality Assurance and Regulatory Affairs.
Your Mission
As Global Director QA/RA - Quality & Regulatory Excellence, you will lead Eurotrol’s Quality Assurance, Regulatory Affairs and Quality Control organization and ensure that everything we do reflects the highest standards of quality, compliance and scientific integrity. As Eurotrol’s designated Person Responsible for Regulatory Compliance (PRRC), you will ensure that our organization and products continue to meet the highest standards of regulatory compliance under the EU IVDR, while providing strategic regulatory leadership across our global business.
Your mission is not simply to ensure compliance, it is to make quality a strategic advantage.
You will help shape the quality culture of the organization, guide regulatory strategy, support innovation, and ensure that every product leaving Eurotrol contributes to confidence in diagnostic testing around the world.
Working closely with R&D, Manufacturing, Operations and Commercial teams, you will create an environment where innovation and regulatory excellence reinforce one another. You will lead the continued evolution of our Quality Management System, prepare the organization for future regulatory developments, and ensure our products continue to meet the highest international standards.
As a member of the Executive Management Team, you will help define the strategic direction of the company and ensure that quality remains one of Eurotrol’s greatest competitive strengths.
Ultimately, your work will contribute to something much bigger than compliance.
Every day, laboratories around the world rely on Eurotrol quality controls to verify that their diagnostic systems are performing correctly before patient samples are analyzed. By ensuring the highest standards of quality and regulatory excellence, you will help safeguard the reliability of diagnostic testing, and support better patient care for millions of people worldwide.
What You Will Do
You will provide strategic and operational leadership across all Quality Assurance, Regulatory Affairs and Quality Control activities, including:
- Lead and continuously develop Eurotrol’s Quality Management System.
- Ensure ongoing compliance with international regulations and standards, including ISO 13485, EU IVDR, MDSAP, FDA Quality System Regulation (QSR/QMSR) and other applicable global requirements.
- Serve as Eurotrol’s designated Person Responsible for Regulatory Compliance (PRRC) under the EU IVDR, ensuring that regulatory compliance supports innovation, product excellence and global market access throughout the product lifecycle.
- Drive a company-wide culture where quality is embedded in every process, every project and every decision.
- Lead regulatory strategies supporting new product introductions and international market access.
- Prepare for and lead customer, notified body and regulatory authority audits with confidence and professionalism.
- Oversee CAPA, risk management, change control, complaint handling and post-market surveillance processes.
- Establish meaningful quality metrics and use data to drive continuous improvement.
- Partner closely with R&D, Manufacturing, Operations, Supply Chain and Commercial teams to accelerate innovation while maintaining the highest quality standards.
- Lead, mentor and develop a high-performing QA/RA/QC organization.
- Stay ahead of changing global regulations and translate new requirements into practical business improvements.
- Represent Quality as a strategic function within the executive management team.
What Makes This Position Different?
Unlike many QA/RA positions, you will work in an organization where:
- Quality is our core business, not a support function.
- Our products directly contribute to accurate patient diagnosis worldwide.
- Innovation and regulatory excellence go hand in hand.
- You will have real influence on company strategy.
- Decisions are made quickly in an entrepreneurial environment.
- You will work with highly specialized technologies that few companies in the world develop.
If you enjoy building, improving and leading rather than simply maintaining, you will thrive here.
Who We Are Looking For
You are an experienced QA/RA leader who combines regulatory expertise with business insight and natural leadership. You understand that world-class quality is not created by procedures alone - it is created by people, culture and continuous improvement.
Ideally you bring:
- A university degree in Life Sciences, Biomedical Sciences, Biotechnology, Chemistry or a related discipline.
- Extensive leadership experience in Quality Assurance and Regulatory Affairs within the medical device or IVD industry.
- Strong knowledge of ISO 13485, EU IVDR, FDA regulations and global quality management systems.
- Experience interacting with regulatory authorities, notified bodies and international customers.
- Proven success leading audits and implementing continuous improvement initiatives.
- Excellent leadership and coaching skills.
- Strong analytical thinking combined with pragmatic decision-making.
- Excellent communication skills in both Dutch and English.
Why Eurotrol?
Join an international company where innovation, science and quality come together. You’ll work alongside passionate colleagues developing products that help laboratories around the world deliver reliable patient results. You’ll influence company strategy, strengthen global quality systems and help shape the future of IVD quality controls.
If you’re looking for a role where your expertise truly matters, we’d love to meet you.
Ready to Make a Difference?
Please send your CV and motivation letter to [email protected].
Become part of Eurotrol and help build the quality behind healthcare.
Because confidence in patient results starts with confidence in quality.
