Senior Regulatory Business Analyst

Roche Digital Technology (RDT) is a global team at Roche focused on powering the company through digital technologies including artificial intelligence and scalable tech innovations in the healthcare industry. Diagnostics R&D at Roche operates at the intersection of science, technology, and regulation, developing AI systems, agentic platforms, and multi-modal data pipelines while ensuring compliance.

• Bachelor’s degree in Computer Science, Information Technology, Legal Studies, or related field.
• 5+ years of Business Analysis/Consultancy experience, including 3+ years in life sciences/pharma or related function.
• Hands-on experience with 21 CFR Part 11, GxP, ALCOA+, GDPR, HIPAA, and EU AI Act; knowledge of Software as a Medical Device (SaMD).
• Proficiency in Business Analysis practices including requirements elicitation, documentation, traceability, and change management.
• Experience with frameworks such as BPMN, SWOT, gap analysis, and risk management.
• Familiarity with Agile Lifecycle Tools (Jira, Confluence, Retina) and Diagramming/Mockup Tools (Visio, Miro, Lucidchart, AI prototyping).
• Strong communication, conflict resolution, and consensus-building skills.
• Preferably holds CBAP certification or equivalent; PMP certification is a plus.

• Independently manage end-to-end business analysis workstreams.
• Lead analysis of complex business problems and conduct domain research.
• Facilitate alignment workshops and risk-review sessions with stakeholders across Legal, Quality Assurance, Software Engineering, and Validation.
• Analyze and map multi-modal R&D workflows and assess automated agentic pipelines for business impact.
• Evaluate R&D platforms and software tools against 21 CFR Part 11, GxP standards, and ALCOA+ principles.
• Define requirements for audit trail design and privacy compliance with GDPR and HIPAA.
• Translate requirements into strategic implementation plans and contribute to solution roadmaps.

The position requires work in Warsaw Grafit office with a hybrid model of on average two days per week in the office. The employer processes personal data for recruitment in accordance with applicable laws and provides information on data protection and whistleblowing procedures.