Role: Business Analyst - Regulatory & Clinical Affairs
Location: Santa Clara, CA – Onsite
Fulltime – Permanent
Job Description
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.