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
At Thirona, quality and regulatory affairs are part of how we build our AI-driven medical software. Our development processes are anchored in a certified ISO 13485 Quality Management System and aligned with established medical device and data governance frameworks, giving customers, clinical partners, and ultimately patients confidence in both the safety and reliability of our solutions.
In this role, you will join the QA/RA team and work closely across R&D, operations, and commercial teams, helping ensure that quality and regulatory thinking are embedded in everyday decisions and workflows.
You will have the space to shape, challenge, and improve our QMS, keeping it not only compliant, but also practical and well-tuned to a fast-moving, innovation-driven environment.
In this role you will
- Work across the full spectrum of quality and regulatory activities, from CAPA, complaint handling, and risk management to supplier qualification, audits, and continuous QMS improvement
- Translate regulatory requirements into clear, actionable practices for teams across the organization, fostering a culture where quality is understood, owned, and continuously improved
- Collaborate closely with R&D to ensure that every solution meets high standards
- Work with operations team to make sure external processes, including distributor management, meet quality and regulatory standards
Your profile
- You understand both sides of the equation: the discipline of regulatory frameworks and the dynamics of developing advanced medical software
- You have experience obtaining 510(k) clearance and MDR certification for medical devices (experience with software-based medical devices is a plus)
- You are knowledgeable on EU MDR (2017/745), FDA Quality System Regulation (21 CFR Part 820/QMSR), and familiarity with the EU AI Act is a plus
- You have a solid understanding of ISO 13485 and ISO 14971
- You know how to keep processes aligned with rapidly evolving standards and regulations.
- You bring 4+ years of experience in the medical device field and its regulatory landscape preferably in SaMD
- You have completed higher professional education in a relevant field
- You possess strong verbal and written English communication skills
- You are hands-on and pro-active
- You are motivated to drive a quality culture and enjoy building and improving systems
Practical Information
- Your primary workplace will be our office in Nijmegen
- 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
We would love to hear from you
Interested candidates are invited to apply by sending a CV and motivation letter to vacancies@thirona.eu