Regulatory Affairs Officer
Help bring innovative IVD products to healthcare professionals in more than 100 countries.
At Eurotrol, Quality is not a department. It is the promise behind every product we deliver worldwide. Our quality control materials helps laboratories and hospitals around the world verify the accuracy of diagnostic testing, ensuring patients recieve reliable results every day. Behind every product is a dedicated Regulatory Affairs team that makes worldwide market access possible.
At Eurotrol, Quality is not a department. It is the promise behind every product we deliver worldwide.
As our new Regulatory Affairs Officer, you will play a key role in bringing innovative in vitro diagnostic (IVD) products to the global market. Working closely with colleagues, OEM partners, distributors and regulatory authorities worldwide, you will help ensure our products comply with international regulations while supporting the continued growth of an innovative Dutch company with global ambitions.
If you enjoy combining science, international communication and regulatory strategy in a highly collaborative environment, this could be the opportunity you’ve been looking for.
What you will do
As part of our experienced QA/RA team, you will:
- Develop regulatory strategies for new and existing IVD products
- Prepare and coordinate international product registrations
- Communicate with regulatory authorities and regulatory representatives across the globe
- Support OEM manufacturers and distributors with regulatory documentation
- Monitor changing international regulations and assess their impact
- Collaborate closely with R&D, Quality Assurance, Product Development and Operations
- Contribute to maintaining our high regulatory standards and global compliance
- Help bring innovative products from development to worldwide commercialization
Every day is different. One day you may be discussing a registration strategy for South America, the next day supporting an OEM customer in Asia or preparing documentation for Europe under IVDR.
Who you are
You are curious, analytical and enjoy working in an international environment where accuracy really matters.
You have:
- Bachelor’s or Master’s degree in Life Sciences, Biomedical Sciences, Biotechnology, Regulatory Affairs or a related field
- Excellent communication skills in Dutch and English
- Strong organizational and planning skills
- An eye for detail without losing sight of the bigger picture
- A proactive and solution-oriented mindset
- The ability to work independently as well as within a multidisciplinary team
Experience with IVD, Medical Devices, ISO 13485, IVDR or international product registrations is an advantage, but above all, we are looking for someone eager to learn and grow.
Why Eurotrol?
Joining Eurotrol means joining a company where your work truly makes a difference.
We offer:
- An international role with worldwide impact
- A modern and innovative company with ambitious growth plans
- The opportunity to work on products used by hospitals across the globe
- A highly experienced QA/RA team where knowledge sharing is part of our culture
- Plenty of room for personal development and professional growth
- Short communication lines and the opportunity to make a real contribution
- Excellent employment conditions and a competitive salary
- A healthy work-life balance
- A workplace where quality, innovation and teamwork go hand in hand
Why this role matters
Every laboratory result starts with confidence.
By helping ensure our products meet international regulatory requirements, you contribute directly to safer diagnostics and better healthcare for millions of patients worldwide.
That is something to be proud of.
About Eurotrol
Eurotrol develops and manufactures premium quality control materials for In Vitro Diagnostics (IVD). Our products are used daily in hospitals and laboratories in more than 100 countries to verify the reliability of diagnostic testing.
Innovation, quality and customer focus have been the foundation of our success for decades. As we continue to grow internationally, we are looking for talented people who want to grow with us.
Ready to make a global impact?
We would love to meet you.
