QA/RA Officer, Nijmegen

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, not only in terms of compliance, but also clinical reliability and performance• Partner with business development and operations to ensure that external collaborations, including distributors, meet the same level of quality and regulatory rigor

Your profile• You understand both sides of the equation: the discipline of regulatory frameworks and the dynamics of developing advanced medical software • You are motivated to drive a quality culture and enjoy building and improving systems • You bring 4+ years of experience in the medical device fieldand its regulatory landscape• You have completed higher professional education in a relevant field • You possess strong verbal and written English communication skills • You have a solid understanding of ISO 13485 and ISO 14971 • You are familiar with EU MDR (2017/745), FDA Quality System Regulation (21 CFR Part 820/QMSR), and ideally 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 discussedYou 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 NijmegenAn 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