Business Analyst - Medical Device Regulatory

Business Analyst - Medical Device Regulatory & Clinical Affairs (AI Automation)

Experience: 4-6 Years
Relevant Business Analyst Experience: 3-5 Years
Industry Experience: Minimum 2 Years in Medical Devices / MedTech
Location: Santa Clara, California
Primary Skill: Medical Device & Regulations

Job Summary

We are seeking an experienced Business Analyst with a strong background in the medical device/MedTech industry, specifically supporting Regulatory Affairs and/or Clinical Affairs processes. The ideal candidate will assess existing business workflows, identify process gaps, and recommend opportunities for AI-enabled automation, intelligent workflows, analytics, and digital transformation.

The candidate must be comfortable working independently with cross-functional stakeholders, translating business needs into clear requirements, and ensuring proposed solutions align with regulatory, clinical, quality, privacy, and validation expectations.

Key Responsibilities

• Assess current Regulatory Affairs and Clinical Affairs workflows, including business objectives, systems, data, controls, dependencies, and pain points.
• Identify opportunities for AI, intelligent automation, workflow automation, analytics, and process improvement.
• Evaluate use cases based on business value, technical feasibility, implementation effort, operational risk, and regulatory impact.
• Develop problem statements, opportunity assessments, business cases, business requirements, and functional requirements.
• Create current-state and future-state process maps, business rules, data flows, user stories, acceptance criteria, and traceability documentation.
• Facilitate discovery workshops, stakeholder interviews, requirements reviews, and prioritization sessions.
• Collaborate with Regulatory Affairs, Clinical Affairs, Quality, IT, Data/AI, Privacy, and Security teams to define and validate solution requirements.
• Identify process gaps, control weaknesses, manual effort, root causes, and measurable improvement opportunities.
• Support solution evaluation, backlog refinement, testing, UAT readiness, implementation planning, and change adoption.
• Ensure proposed solutions consider applicable regulatory requirements, clinical risks, quality systems, data privacy, validation, documentation, and audit-trail requirements.
• Prepare executive-ready presentations, dashboards, summaries, and recommendations for stakeholders, including senior leadership and VP-level audiences.
• Track project risks, assumptions, dependencies, decisions, and success metrics, escalating issues when required.

Mandatory Technical / Functional Skills

• 3-5 years of relevant Business Analyst experience, ideally around 5 years.
• Minimum 2 years of experience in the medical device/MedTech industry.
• Direct experience supporting Regulatory Affairs and/or Clinical Affairs business processes.
• Strong understanding of regulated medical device workflows, quality systems, documentation controls, and regulatory expectations.
• Experience assessing current-state processes and defining future-state workflows.
• Ability to identify AI, intelligent automation, analytics, and workflow-improvement opportunities.
• Strong skills in business and functional requirements, problem statements, user stories, acceptance criteria, process mapping, and traceability.
• Experience conducting gap analysis, root cause analysis, data analysis, and defining KPIs.
• Understanding of regulatory, clinical, quality, privacy, validation, and audit-trail considerations for automated solutions.
• Strong stakeholder management, workshop facilitation, documentation, and presentation skills.
• Proficiency in Microsoft Excel, PowerPoint, Word, and Visio or equivalent process-mapping tools.

Preferred Skills

• Experience with AI-enabled business solutions and intelligent automation initiatives.
• Exposure to digital transformation and workflow modernization projects.
• Familiarity with Agile tools, requirements management, and backlog refinement.
• Experience preparing executive-level business cases and recommendations.
• Ability to work with individual contributors, managers, directors, and VP-level stakeholders.