Key Skills

Job Description

Team Lead QA/RA Nijmegen (GLD) About Thirona: Thirona is a fast-growing global company specializing in AI-assisted medical image analysis. Since its inception in 2014, we have grown from a science-based startup to a market leader in AI-powered analysis for pulmonary imaging. We work with pharmaceutical and med-tech companies, helping them to advance drug and treatment development, as well as implement innovations in precision medicine in clinical care. Through our integration partners, Thirona’s AI software is also being used by medical specialists in hospitals and health care providers across the globe. With 20 different nationalities and variations of backgrounds, we form a naturally diverse team. We seek talent, but never at the cost of personality. 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. This gives customers, clinical partners and ultimately patients confidence in the safety and reliability of our solutions. As Team Lead QA/RA, you set the direction for quality and regulatory affairs at Thirona. In a small, growing company, this means combining leadership with hands-on work: you coach and develop your team, translate our business ambitions into a clear QA/RA strategy, and are the go-to partner for management on all quality and regulatory topics. You work closely with R&D, operations and commercial teams to embed quality and regulatory thinking in everyday decisions and workflows. You 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 (not an exhaustive list): Lead the QA/RA team: set priorities, divide the work and support each team member’s growth Define and drive the QA/RA strategy and roadmap, in line with Thirona’s product pipeline, target markets and business goals Advise management on regulatory pathways, compliance risks and required resources, and report on QMS performance Represent Thirona towards notified bodies, regulatory authorities and auditors Stay hands-on across the full spectrum of quality and regulatory activities, from CAPA, complaint handling and risk management to supplier qualification, audits and continuous QMS improvement Lead or participate in the CAPA review board and the complaint handling board, and partner with other stakeholders to proactively address risks 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 Support our service department in delivering consistently high-quality output, in line with our quality standards and regulatory requirements Support distributor management and other external processes, so that external collaborations meet the same level of quality and regulatory rigor Profile: Completed higher professional education in a relevant field 7+ years of experience in the medical device field and its regulatory landscape, preferably in Software as a Medical Device (SaMD) Proven experience leading or coaching a team, preferably within QA/RA Experience obtaining 510(k) clearance and MDR certification for medical devices; experience with software-based medical devices is a plus Solid understanding of ISO 13485 and ISO 14971 Knowledge of EU MDR (2017/745) and the FDA Quality System Regulation (21 CFR Part 820/QMSR); familiarity with the GDPR and the EU AI Act is a plus Strong verbal and written English communication skills Competences: Understanding of both sides of the equation: the discipline of regulatory frameworks and the dynamics of developing advanced medical software Strategic thinker; able to set clear priorities in a small organization with limited resources Builds trust and communicates clearly with both management and the team Firm on compliance, combined with a pragmatic approach Hands-on and proactive Motivated to drive a quality culture; enjoys building and improving systems Able to keep processes aligned with rapidly evolving standards and regulations Practical information: Office location: Nijmegen Hybrid working: up to 40% of your working time from home Up to 8 weeks per year to work remotely or from abroad Preferably full-time; part-time employment can be discussed 27 vacation days based on a 40-hour contract 8% holiday allowance, paid annually in May 8% pension contribution with a flexible pension plan EU passport or valid EU work permit is required for this job position A reference check may be part of the recruitment process Why should you choose us? We offer a competitive salary and plenty of personal development opportunities We are proud to have a positive impact on patients’ healthcare We are a friendly and energetic team of professionals We work hard but have fun together We keep growing and like to see you growing with us We would love to hear from you! Please email your CV and motivation letter to [email protected]. Kindly note that applications via LinkedIn will not be considered. Acquisition for this vacancy is not appreciated.

Core Responsibilities

Lead and develop the QA/RA team, set the quality and regulatory strategy, and advise management on regulatory pathways, compliance risks, and QMS performance. Oversee hands-on quality and regulatory activities, represent the company to regulators and auditors, and work across teams to improve the QMS and embed quality practices.

Requirements

Requires higher professional education in a relevant field, at least seven years of medical device experience, and experience leading or coaching a team. Candidates should have experience with 510(k) clearance and MDR certification, strong knowledge of ISO 13485, ISO 14971, EU MDR, and FDA quality regulations, and strong English communication skills.

Benefits

• Competitive Salary
• Personal Development Opportunities
• Hybrid Working
• Remote Work From Abroad
• 27 Vacation Days
• 8% Holiday Allowance
• 8% Pension Contribution
• Flexible Pension Plan