| Location | Irvine, CA |
| Salary | $31.81–$39.39 Per Hour |
Job Title: Business Analyst
Location: Irvine, California
Duration: 6 months
Experience Required: 4–6 years
Target Experience: Approximately 5 years of Business Analyst experience
Essential Skill: Medical Device & Regulations
Industry: Medical Devices / MedTech
Focus Areas: Regulatory Affairs, Clinical Affairs, AI, Automation, and Digital Transformation
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 points
Control gaps
Manual efforts
Workflow inefficiencies
AI-enabled automation opportunities
Experience translating business needs into:
Problem statements
Business requirements
Functional requirements
User stories
Acceptance criteria
Process maps
Traceability documentation
Working 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 Excel
Microsoft PowerPoint
Microsoft Word
Microsoft Visio or equivalent process-mapping tools
Experience 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.
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 statements
Problem statements
Business cases
Current-state and future-state process maps
Business and functional requirements
User stories and acceptance criteria
Requirements traceability documentation
Collaborate with cross-functional stakeholders, including:
Regulatory Affairs
Clinical Affairs
Quality Assurance
Information Technology (IT)
Data and AI teams
Privacy and Security teams
Other relevant business functions
Facilitate 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.
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.
Business Analysis
Medical Device and MedTech Industry Experience
Regulatory Affairs
Clinical Affairs
Medical Device Regulatory Requirements
AI and Artificial Intelligence
Intelligent Automation
Workflow Automation
Process Assessment and Process Mapping
Current-State and Future-State Analysis
Gap Analysis and Root Cause Analysis
Business Requirements and Functional Requirements
User Stories and Acceptance Criteria
Requirements Traceability
Stakeholder Management
Workshop Facilitation
User Acceptance Testing (UAT)
Validation and Documentation Controls
Data Privacy and Quality Systems
Digital Transformation
KPI Definition and Data Analysis
Business Analyst
Medical Device
MedTech
Regulatory Affairs
Clinical Affairs
AI
Artificial Intelligence
Automation
Intelligent Automation
Process Assessment
Process Mapping
Current State
Future State
Gap Analysis
Problem Statement
Business Requirements
Functional Requirements
User Stories
Acceptance Criteria
Traceability
Stakeholder Management
Workshop Facilitation
UAT
Validation
Data Privacy
Quality Systems
Digital Transformation
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.
1. Business Analyst Experience: Does the candidate have 3–5 years of Business Analyst experience, with approximately 5 years preferred?
2. Medical Device Experience: Does the candidate have at least 2 years of experience in the medical device or MedTech industry?
3. Regulatory/Clinical Affairs: Has the candidate directly supported Regulatory Affairs and/or Clinical Affairs business processes?
4. AI and Automation: Can the candidate independently assess current-state processes and identify practical AI or automation opportunities?
5. Requirements Documentation: Can the candidate create problem statements, process maps, business requirements, functional requirements, user stories, acceptance criteria, and traceability documentation?
6. Stakeholder Management: Has the candidate engaged with and presented to stakeholders ranging from individual contributors to VP-level leadership?
7. Regulatory Compliance: Does the candidate understand regulatory, clinical, quality, privacy, validation, and audit-trail considerations for AI or automated solutions?
8. Availability and Location: Is the candidate available for the stated contract duration and willing to work onsite in Santa Clara, California, if required?
Important clarification: The primary job details specify a 6-month contract in Irvine, California, while the final screening question mentions a 2–3-month contract and onsite work in Santa Clara, California. Confirm the actual contract duration and work location with the recruiter before screening candidates.