Team Lead QA/RA

Thirona; Nijmegen; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid work

Remote work up to 8 weeks/year

27 vacation days

8% holiday allowance

8% pension

Job summary

Thirona BV is seeking a Team Lead QA/RA to set the direction for quality and regulatory affairs in a small, fast-growing company. You will coach and develop the team, translate business ambitions into a QA/RA strategy, and be the go-to partner for management on quality topics.

You will work closely with R&D, operations and commercial teams to embed quality thinking in everyday decisions, shaping the QMS to be compliant yet practical in a fast-moving, AI-driven medical software environment.

Qualifications

• 7+ years of experience in the medical device field and its regulatory landscape.
• Experience obtaining 510(k) clearance and MDR certification for medical devices; software-based medical devices is a plus.
• Solid understanding of ISO 13485 and ISO 14971.
• Strong verbal and written English communication skills.

Responsibilities

• 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 product pipeline 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 CAPA, complaint handling, risk management, supplier qualification, audits and continuous QMS improvement.

Skills

Leadership

QA/RA

Regulatory affairs

ISO 13485

SaMD

English fluency

Education

Higher education

Job description

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:

• 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 [e-mail]. Kindly note that applications via LinkedIn will not be considered.