Product QA/RA Officer

In the fight against breast cancer, every medical image is an opportunity: to unlock insight, to uncover risk, to embody health, to empower life. ScreenPoint’s Transpara Breast AI delivers unmatched precision for breast radiologists and helps define personalized care pathways for every 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 and global compliance. You won’t just be checking boxes; you will be embedded within our design and development lifecycle. You will act as the strategic guardian of product quality and 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, Product Management, 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 feedback loop 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 into the product roadmap from inception to launch. Technical File Ownership: Compile, maintain, and review Technical Files and Design History Files (DHF) to ensure full compliance with EU MDR, FDA, and other global 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 whether product changes necessitate new regulatory filings or notifications. Cross-Functional Guidance: Provide advice to Engineering and Clinical teams on risk management, usability engineering, and software verification/validation strategies. Global Submissions Support: Support global market access by providing high-quality technical documentation for EU MDR, US 510(k), and other international registrations. Job requirements You are a technically-minded QA/RA professional who enjoys getting under the hood of software products. You balance a meticulous eye for detail with a pragmatic approach to problem-solving. Experience: At least 3 years of experience in QA/RA specifically focused on Medical 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 EU MDR. Analytical Mindset: Ability to translate complex regulatory language into actionable technical requirements for developers. Communication: Excellent command of English, with the ability to explain compliance concepts to non-regulatory stakeholders clearly. Preferred qualifications Experience with AI/Machine Learning validation and evolving cybersecurity frameworks. 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? Please apply using the application button. 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? Please send an email to [email protected].