Product QA/RA Officer

ScreenPoint Medical; Nijmegen; On-site; EUR 70,000 - 90,000; Full time

Job summary

ScreenPoint Medical is seeking a Product QA/RA Officer to bridge innovative engineering and global compliance. You will own Technical Files and DHF, ensure MDR/FDA readiness, and guide cross-functional teams in risk management and software verification.

The role emphasizes AI-enabled regulatory research and vigilant post-market surveillance. You will collaborate with Engineering, Product Management, and Clinical teams to ensure compliant-by-design Breast AI innovations reach clinicians safely

Qualifications

• At least 3 years of QA/RA experience in SaMD (medical device software).
• Ability to translate regulatory language into technical requirements for developers.
• Excellent command of English for cross-functional communication.

Responsibilities

• Act as QA/RA stakeholder across design projects; ensure regulatory requirements integrated from inception to launch.
• Own and maintain Technical Files and DHF; ensure EU MDR, FDA and other global requirements compliance.
• Lead post-market surveillance activities; investigate, perform root-cause analysis and ensure timely resolutions.
• Monitor regulatory standards (AI, cybersecurity) and assess impact on product portfolio; flag regulatory filings or notifications when needed.
• Provide guidance on risk management, usability engineering, and software verification/validation strategies to Engineering and Clinical teams.
• Support global submissions by producing high-quality regulatory documentation for EU MDR, US 510(k), etc.
• Promote intelligent use of AI tools to improve regulatory research and QA/RA processes, ensuring compliance.

Skills

QA/RA expertise

Regulatory translation

English communication

Education

Technical degree in Software Engineering

Biomedical Engineering

Tools

Claude

ChatGPT

Job description

In the fight against breast cancer, every medical image is an opportunity: to unlock insight, touncover risk, to embody health, to empower life. ScreenPoint’s Transpara Breast AI deliversunmatched precision for breast radiologists and helps define personalized care pathways forevery woman we serve. Make your mark as part of The Breast AI Company.

As our Product QA/RA Officer, you are the bridge between innovative engineering andglobal compliance. You won’t just be checking boxes; you will be embedded within ourdesign and development lifecycle. You will act as the strategic guardian of product qualityand regulatory alignment, ensuring that our Breast AI innovations are built "compliant by design" and reach clinicians safely and efficiently.

In this role, you provide hands‑on support and guidance to the Engineering, ProductManagement, and Clinical teams. You ensure that our Technical Files are not just complete,but robust enough to stand up to global scrutiny, while managing the post-market feedbackloop that keeps our products at the forefront of the industry.

Your responsibilities

• Design & Development Partnership: Act as the primary QA/RA stakeholder in all
  product-related design projects. Ensure regulatory requirements are integrated intothe product roadmap from inception to launch.
• Technical File Ownership: Compile, maintain, and review Technical Files andDesign History Files (DHF) to ensure full compliance with EU MDR, FDA, and otherglobal requirements.
• Post-Market Surveillance & Vigilance: Support with product-related complaints and nonconforming products. Lead investigations, perform root cause analysis, and ensure timely resolution.
• Regulatory Intelligence & Standards: Monitor and analyze evolving (technical)standards (e.g., AI, Cybersecurity) for impact on our portfolio. Determine whetherproduct changes necessitate new regulatory filings or notifications.
• Cross-Functional Guidance: Provide advice to Engineering and Clinical teams onrisk management, usability engineering, and software verification/validationstrategies.
• Global Submissions Support: Support global market access by providing high-quality technical documentation for EU MDR, US 510(k), and other internationalregistrations.
• Proactively use AI tools to improve regulatory research, documentation, analysis, and internal QA/RA processes, while ensuring outputs are reviewed appropriately and remain compliant with applicable quality and regulatory requirements.

Job requirements

You are a technically‑minded QA/RA professional who enjoys getting under the hood ofsoftware products. You balance a meticulous eye for detail with a pragmatic approach toproblem-solving.

• Experience: At least 3 years of experience in QA/RA specifically focused onMedical Device Software (SaMD).
• Educational Background: A technical degree (e.g., Software Engineering,Technical Medicine, Biomedical Engineering) or equivalent technical experience.
• Standard Expertise: Deep knowledge medical device standards such as IEC 62304(Software Lifecycle), ISO 14971 (Risk Management), and IEC 62366 (Usability).
• Regulatory Knowledge: Familiarity with FDA regulations (21 CFR 820) and EUMDR.
• Analytical Mindset: Ability to translate complex regulatory language into actionabletechnical requirements for developers.
• Communication: Excellent command of English, with the ability to explaincompliance concepts to non-regulatory stakeholders clearly.
• An AI-positive mindset, with the ability to use tools such as Claude, ChatGPT, or similar technologies responsibly to improve efficiency, quality, and consistency in day‑to‑day QA/RA work.

Preferred qualifications

• Experience with AI/Machine Learning validation and evolving cybersecurityframeworks.
• Knowledge of cloud-based SaaS deployments in a regulated environment.
• Experience with breast radiology workflows, oncology, or medical imaging (DICOM).

About us

ScreenPoint Medical is a leading company that develops and markets breast image analysis and cutting edge machine learning applications and services. Our product Transpara improves breast cancer survival rates by detecting cancers earlier so that treatment can be more effective and less invasive.

Do you want to help us build an innovative solution to improve health worldwide? And do you want to be part of an ambitious and fast-growing team who help you develop your career further?

Providing a Certificate of Conduct (VOG) or background check is part of our application procedure. Questions about the contents of the vacancy or the recruitment process at ScreenPoint Medical?