Business Analyst Must Have Technical/Functional Skills 3-5 years of relevant Business Analyst experience, with a target of approximately 5 years. Minimum 2 years of experience in the medical device/MedTech sector, specifically supporting Regulatory Affairs and/or Clinical Affairs processes. Strong understanding of regulated medical device business processes, quality systems, documentation controls, and applicable regulatory expectations. Ability to independently assess current-state workflows, identify pain points, control gaps, manual effort, and opportunities for AI-enabled automation. Experience translating business needs into clear problem statements, business requirements, functional requirements, user stories, acceptance criteria, and process maps. Working knowledge of AI, intelligent automation, workflow automation, analytics, and digital transformation concepts, including identification of appropriate use cases and business value. Ability to evaluate proposed solutions for regulatory, clinical, data privacy, quality, validation, traceability, and change-management considerations. Experience facilitating discovery workshops, stakeholder interviews, requirements reviews, and prioritization sessions. Strong analytical skills with proficiency in process mapping, gap analysis, root cause analysis, data analysis, and KPI definition. Proficiency with Microsoft Office tools, including Excel, PowerPoint, Word, Visio or equivalent process-mapping tools; experience with requirements or agile tools is preferred. Excellent written and verbal communication skills, with the ability to engage stakeholders from individual contributors through VP-level leadership.
Roles & Responsibilities:
Independently assess Regulatory Affairs and Clinical Affairs business processes to understand objectives, workflows, systems, data, controls, pain points, and dependencies.
Identify and evaluate AI, automation, analytics, and workflow-improvement opportunities based on business value, feasibility, risk, and regulatory impact.
Develop concise opportunity statements, problem statements, business cases, process maps, requirements, user stories, acceptance criteria, and traceability documentation.
Partner with Regulatory Affairs, Clinical Affairs, Quality, IT, Data/AI, Privacy, Security, and other cross-functional stakeholders to validate needs and align on solution scope.
Facilitate workshops and interviews with stakeholders at all levels, from individual contributors to VP leadership, and communicate findings in a clear, decision-oriented format.
Document current-state and future-state processes, business rules, data flows, roles, handoffs, risks, assumptions, and success measures.
Prioritize use cases and requirements; support solution evaluation, backlog refinement, testing/UAT readiness, implementation planning, and change adoption.
Ensure proposed solutions maintain appropriate regulatory, clinical, quality, privacy, validation, documentation, and audit-trail considerations.
Prepare executive-ready summaries, presentations, dashboards, and recommendations that enable timely decisions.
Drive assigned work independently within the short-term contract timeline and escalate decisions, risks, and dependencies promptly.
Salary Range: $75,000-$83,000 a year
Location: Santa Clara, CA
