About the role
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 structure business requirements from cross-functional stakeholders
* Translate needs into functional specifications, user stories and clear acceptance criteria
* Ensure 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 sessions
* Design and execute manual test cases based on defined requirements
* Maintain high-quality documentation (specifications, validation protocols, test documentation)
* Collaborate closely with Product Owner, development and quality team
Profile
* Senior experience in Business Analysis or Requirements Engineering
(minimum 5 years relevant experience)
* Strong capability in requirements structuring and process modelling
* Experience working in regulated or quality-driven environments
* Data analysis capability (SQL, Excel, BI tools)
* Solid understanding of SDLC; Agile/Scrum is a plus
* Fluent in French and professional proficiency in English
Nice to have
* Scientific background
* Exposure to healthcare, laboratory or regulated environments
* Experience with software integration in complex client IT ecosystems
* Familiarity with ISO 13485, medical devices or IVD environments
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.
Confidential process.