On 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 responsibilities
Gather, analyze and document business requirements from cross‑functional stakeholders
Create functional specifications, user stories and acceptance criteria
Develop and maintain requirements traceability in line with ISO 13485 standards
Facilitate stakeholder meetings and requirement validation workshops
Design and execute manual test cases based on business requirements and acceptance criteria
Maintain documentation including requirements specifications, test plans and validation protocols
Partner with Product Owner and development teams to ensure alignment between business needs and technical solutions
Profile
Senior experience in Business Analysis or Requirements Engineering (minimum 5 years expected)
Process/workflow modelling experience (UML and BPMN are a plus)
Data analysis capability using Excel, BI tools and SQL
Good understanding of SDLC; familiarity with Agile/Scrum methodologies is a plus
Fluent in French and professional proficiency in English
Nice to have
Scientific background
Experience in a regulated environment (ISO, FDA, medical devices/IVD)
Exposure to healthcare or laboratory workflows
Experience with automated testing tools (Cypress or Playwright)
How to apply
Send your CV to job@talent-up.be with “Senior Business Analyst” in the subject line, or contact me directly via private message on LinkedIn.
#J-18808-Ljbffr