Business Analyst

Business AnalystLocation: Irvine, CaliforniaDuration: 6 monthsExperience Required: 4–6 yearsTarget Experience: Approximately 5 years of Business Analyst experienceEssential Skill: Medical Device & RegulationsIndustry: Medical Devices / MedTechFocus Areas: Regulatory Affairs, Clinical Affairs, AI, Automation, and Digital TransformationMust-Have Technical/Functional Skills:3–5 years of relevant Business Analyst experience, with approximately 5 years preferred.Minimum 2 years of experience in the medical device or MedTech industry.Direct experience supporting Regulatory Affairs and/or Clinical Affairs business processes.Strong understanding of regulated medical device business processes, quality systems, documentation controls, and regulatory requirements.Ability to independently assess current-state workflows and identify:Process pain pointsControl gapsManual effortsWorkflow inefficienciesAI-enabled automation opportunitiesExperience translating business needs into:Problem statementsBusiness requirementsFunctional requirementsUser storiesAcceptance criteriaProcess mapsTraceability documentationWorking knowledge of AI, intelligent automation, workflow automation, analytics, and digital transformation.Ability to identify and evaluate AI and automation use cases based on business value, feasibility, risk, and regulatory impact.Understanding of 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, including process mapping, gap analysis, root cause analysis, data analysis, and KPI definition.Proficiency in Microsoft Office tools, including:Microsoft ExcelMicrosoft PowerPointMicrosoft WordMicrosoft Visio or equivalent process-mapping toolsExperience with requirements management or Agile tools is preferred.Excellent written and verbal communication skills, including the ability to communicate with individual contributors through VP-level leadership.Roles and Responsibilities:Independently assess Regulatory Affairs and Clinical Affairs business processes to understand objectives, workflows, systems, data, controls, pain points, and dependencies.Identify and evaluate opportunities for AI, automation, analytics, and workflow improvements.Assess proposed opportunities based on business value, technical feasibility, risk, and regulatory impact.Develop and document:Opportunity statementsProblem statementsBusiness casesCurrent-state and future-state process mapsBusiness and functional requirementsUser stories and acceptance criteriaRequirements traceability documentationCollaborate with cross-functional stakeholders, including:Regulatory AffairsClinical AffairsQuality AssuranceInformation Technology (IT)Data and AI teamsPrivacy and Security teamsOther relevant business functionsFacilitate workshops and stakeholder interviews across different organizational levels, from individual contributors to VP-level leadership.Document business processes, business rules, data flows, roles, handoffs, risks, assumptions, and success metrics.Prioritize business use cases and requirements based on value, feasibility, and business needs.Support solution evaluation, backlog refinement, testing readiness, User Acceptance Testing (UAT), implementation planning, and change adoption.Ensure proposed solutions address regulatory, clinical, quality, privacy, validation, documentation, and audit-trail requirements.Prepare executive-ready summaries, presentations, dashboards, and recommendations to support business decisions.Independently manage assigned deliverables within the contract timeline.Identify and escalate risks, dependencies, and decisions requiring stakeholder intervention.Drive measurable process improvements and support digital transformation initiatives.Generic Managerial Skills:Self-directed, proactive, and capable of quickly understanding complex, regulated business processes.Strong stakeholder management and relationship-building skills.Excellent workshop facilitation, interviewing, and influencing skills.Ability to communicate effectively with individual contributors, managers, directors, and VP-level executives.Strong problem-solving skills and the ability to structure ambiguous business problems.Ability to synthesize complex information into actionable recommendations.Excellent organization, prioritization, documentation, and follow-through.Ability to work independently in a fast-paced environment.Collaborative, pragmatic, detail-oriented, and focused on measurable outcomes.Essential Skills:Business AnalysisMedical Device and MedTech Industry ExperienceRegulatory AffairsClinical AffairsMedical Device Regulatory RequirementsAI and Artificial IntelligenceIntelligent AutomationWorkflow AutomationProcess Assessment and Process MappingCurrent-State and Future-State AnalysisGap Analysis and Root Cause AnalysisBusiness Requirements and Functional RequirementsUser Stories and Acceptance CriteriaRequirements TraceabilityStakeholder ManagementWorkshop FacilitationUser Acceptance Testing (UAT)Validation and Documentation ControlsData Privacy and Quality SystemsDigital TransformationKPI Definition and Data AnalysisKey Resume Search Keywords:Business AnalystMedical DeviceMedTechRegulatory AffairsClinical AffairsAIArtificial IntelligenceAutomationIntelligent AutomationProcess AssessmentProcess MappingCurrent StateFuture StateGap AnalysisProblem StatementBusiness RequirementsFunctional RequirementsUser StoriesAcceptance CriteriaTraceabilityStakeholder ManagementWorkshop FacilitationUATValidationData PrivacyQuality SystemsDigital TransformationExperience Requirements:Overall experience: 4–6 years.Business Analyst experience: 3–5 years, with approximately 5 years preferred.Medical device/MedTech experience: Minimum 2 years.Regulatory/Clinical Affairs experience: Direct experience supporting at least one of these functions.AI and automation experience: Ability to assess processes and identify practical automation opportunities.Documentation experience: Proven ability to develop requirements, process maps, user stories, acceptance criteria, and traceability documentation.Stakeholder experience: Ability to facilitate discussions and present recommendations to senior leadership.Pre-Screening Questionnaire:1. Business Analyst Experience: Does Talent Software Services