Product QARA Officer

In the fight against breast cancer every medical image is an opportunity: to unlock insight touncover risk to embody health to empower life. ScreenPoints 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 wont 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 completebut 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.

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 on
  Medical Device Software (SaMD).
  
• Educational Background: A technical degree (e.g. Software EngineeringTechnical 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 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

Required Experience:

Unclear Seniority

Employment Type : Full-Time
Experience: years
Vacancy: 1