About Thirona:
Thirona is a global company specializing in AI-based analysis of medical lung images. Our LungQ® technology enables high-precision, automatic assessment of pulmonary diseases.
Developed in collaboration with established research institutions and academic hospitals, our AI software solutions are used to accelerate imaging-based respiratory clinical trials and advance minimally invasive interventions. LungQ® has been validated in more than 250 peer-reviewed publications and is currently used in over 1,200 hospitals worldwide, contributing to pulmonary precision medicine.
With more than 15 nationalities and diverse backgrounds, we form an international and inclusive team. We value expertise, curiosity, and personality in equal measure.
About the vacancy
The Quality Assurance and Regulatory Affairs Officer will join the (QA/RA) team. The QA/RA team contributes to Thirona’s mission by ensuring quality and regulatory compliance in the development of medical devices and related health services worldwide. The team develops, implements, maintains, and continuously improves Thirona’s Quality Management System (QMS) and regulatory processes in accordance with international standards, industry best practices, and customer requirements. As a Quality Assurance and Regulatory Affairs Officer, you will report to the QA/RA Team Lead.
In this role you will
- Drive continuous improvement through CAPA management, Complaint Management, Internal auditing, Supplier/Distributor Management and Risk management activities
- Support the development, implementation, and maintenance of quality and regulatory processes to ensure compliance with applicable regulatory requirements and standards, including ISO 13485, Quality Management System Regulation (21 CFR Part 820), Medical Device Single Audit Program and the EU AI Act.
- Promote a culture of quality within the organization, and provide training and guidance to colleagues on quality assurance processes and requirements
- Identify, initiate, and follow up on changes in the QMS
- Support the internal and external audits, and follow up on audit findings
- Work with R&D teams to ensure that all health products supplied by Thirona are developed and delivered in accordance with applicable policies, standards, regulations, and customer requirements.
- Manage Thirona’s distributor qualifications and related activities, in close collaboration with Thirona’s business development and operational teams, including maintenance of documentation related to approvals
Your profile
- Higher professional education and 4 years of relevant work experience
- Excellent verbal and written English communication skills
- Good understanding of ISO 13485 quality management systems
- Good understanding of ISO 14791 risk management
- Knowledge of the (EU) 2017/745 Medical Device Regulations
- Knowledge of the FDA – Quality System Regulation (QMSR) / 21 CFR Part 820
- Knowledge of the EU AI Act
Practical Information
- Your primary workplace will be our office in Nijmegen
- We offer a hybrid working model, with up to 40% of your working time from home
- You can receive up to 8 weeks per year to work remotely or from abroad
- This position is preferably full-time; part-time employment can be discussed
- You will receive 27 vacation days per year, based on a 40-hour contract
- In addition, you will receive 8% holiday allowance, paid annually in May
- We provide an 8% pension contribution and offer access to a flexible pension scheme
- You are expected to live within approximately one hour travel distance from Nijmegen
- An EU passport or a valid EU work permit is required for this position
- A reference check may be part of the recruitment process
Timeline
Application deadline: 31 March 2026
We would love to hear from you
Interested candidates are invited to apply by sending a CV and motivation letter to vacancies@thirona.eu
Please be advised that applications submitted via LinkedIn will not be reviewed;
Acquisition for this vacancy is not appreciated.