Business Analyst

Job Details

• 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

Must-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 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.

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 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.

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 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

Key Resume Search Keywords

• 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

Experience 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 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.