Senior Business Analyst – Medical Software

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 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.

Confidential process.