About the roleOn behalf of one of our partners (exclusive mandate), we are recruiting a Senior Business Analyst to support the development of medical software solutions in a regulated environment. You will act as a key interface between stakeholders, development teams and quality/validation, translating business needs into functional specifications and ensuring compliance with ISO 13485 documentation requirements.Key responsibilitiesGather, analyze and structure business requirements from cross-functional stakeholdersTranslate needs into functional specifications, user stories and clear acceptance criteriaEnsure full requirements traceability in line with ISO 13485 documentation standards Model workflows and processes (BPMN / UML)Contribute to interoperability between the solution and client IT environments (including laboratory information systems)Facilitate validation workshops and stakeholder alignment sessionsDesign and execute manual test cases based on defined requirementsMaintain high-quality documentation (specifications, validation protocols, test documentation) Collaborate closely with Product Owner, development and quality teamProfile Senior experience in Business Analysis or Requirements Engineering (minimum 5 years relevant experience)Strong capability in requirements structuring and process modellingExperience working in regulated or quality-driven environmentsData analysis capability (SQL, Excel, BI tools)Solid understanding of SDLC; Agile/Scrum is a plusFluent in French and professional proficiency in EnglishNice to haveScientific backgroundExposure to healthcare, laboratory or regulated environmentsExperience with software integration in complex client IT ecosystemsFamiliarity with ISO 13485, medical devices or IVD environmentsHow to applySend your CV to job@talent-up.be with “Senior Business Analyst” in the subject line, or contact me directly via private message on LinkedIn.Confidential process.