Analyst, Information Technology
Core
Identify, design, and deliver technology solutions that optimize business processes in Medical, Quality, Regulatory, and Supply Chain functions within a medical device organization.
Role type
Senior Business Analyst (Regulated Healthcare)
Builds
Configurable technology solutions and optimized business workflows
Domain
Medical device / Life sciences / Regulated healthcare
Deliverable
product features
Required skills
Business process mapping, User story development, Validation planning, UAT execution, Requirements translation, Regulatory compliance analysis, Stakeholder facilitation, SDLC management
Preferred skills
GxP/GAMP 5 knowledge, Veeva platform experience, AI project lifecycle understanding
Technologies
Veeva RIM, Veeva PromoMats, GAMP 5, 21 CFR Part 11, ISO 13485
Responsibilities
Partner with business leaders to identify high-value improvement opportunities; Conduct feasibility assessments and prioritize user stories; Lead detailed discovery sessions to understand business workflows; Translate business needs into clear functional requirements; Map current-state and future-state processes; Review and analyze user requirements prior to submission; Support creation and execution of validation deliverables (Plans, Risk Assessments, Traceability Matrices, UAT); Develop user stories, test cases, and training materials; Lead UAT cycles and drive adoption.
Seniority
Senior, hands-on IC