Business Analyst 2

Siri InfoSolutions Inc; Santa Clara (CA); On-site; USD 100,000 - 125,000; Full time

Job summary

Siri InfoSolutions Inc. is seeking a Business Analyst for Regulatory & Clinical Affairs in Santa Clara, CA. This 3+ month contract-to-hire role focuses on AI and automation to optimize regulatory workflows and ensure compliance.

The analyst will collaborate with Regulatory, Clinical, IT, and Privacy teams to map processes, gather requirements, and define user stories and acceptance criteria. The ideal candidate has BA experience, exposure to MedTech, and strong stakeholder management, with

Qualifications

• 3–5 years of BA experience.
• 2+ years in Medical Device/MedTech.
• Experience supporting Regulatory or Clinical Affairs.
• Proficiency with requirements, user stories, acceptance criteria, and traceability.
• Experience with process mapping, gap analysis, workflow assessment, and process improvement.
• Exposure to AI, automation, analytics, or digital transformation.
• Understanding of medical device quality systems, regulatory requirements, data privacy.
• Experience conducting stakeholder interviews, workshops, and UAT.
• Strong communication and stakeholder management.
• Proficiency with Excel, PowerPoint, Word, Visio (or similar).

Responsibilities

• Analyze Regulatory and Clinical Affairs processes, workflows, systems, and pain points.
• Identify opportunities for AI, automation, analytics, and workflow improvements.
• Develop business cases, process maps, requirements, user stories, acceptance criteria, and traceability documentation.
• Work with Regulatory, Clinical, Quality, IT, Data/AI, Privacy, and Security teams.
• Document current-state and future-state processes, business rules, data flows, risks, and dependencies.
• Support solution evaluation, backlog refinement, UAT readiness, implementation, and change adoption.
• Ensure solutions address regulatory, quality, privacy, validation, documentation, and audit-trail requirements.

Skills

Requirements gathering

Functional requirements

User stories

Acceptance criteria

Traceability

Process mapping

Gap analysis

Workflow assessment

AI & automation awareness

Data privacy

Stakeholder interviews

Stakeholder management

Excel/PowerPoint/Word/Visio

Tools

Visio

Excel

PowerPoint

Word

Job description

Role: Business Analyst Regulatory & Clinical Affairs (AI & Automation)
Location: Santa Clara, CA
Duration: 3+ months(Contract to hire)

Experience: 3 5 years of Business Analyst experience
Medical Device/MedTech: 2+ years preferred

Key Requirements:

• 3 5+ years of Business Analyst experience
• 2+ years of Medical Device/MedTech experience
• Experience supporting Regulatory Affairs and/or Clinical Affairs
• Strong experience with requirements gathering, functional requirements, user stories, acceptance criteria, and traceability
• Experience with process mapping, gap analysis, workflow assessment, and process improvement
• Exposure to AI, automation, intelligent automation, analytics, or digital transformation
• Understanding of medical device quality systems, regulatory requirements, documentation controls, validation, and data privacy
• Experience conducting stakeholder interviews, workshops, requirements reviews, and UAT activities
• Strong communication and stakeholder management skills
• Proficiency with Excel, PowerPoint, Word, Visio, or similar tools

Responsibilities:

• Analyze Regulatory and Clinical Affairs processes, workflows, systems, and pain points
• Identify opportunities for AI, automation, analytics, and workflow improvements
• Develop business cases, process maps, requirements, user stories, acceptance criteria, and traceability documentation
• Work with Regulatory, Clinical, Quality, IT, Data/AI, Privacy, and Security teams
• Document current-state and future-state processes, business rules, data flows, risks, and dependencies
• Support solution evaluation, backlog refinement, UAT readiness, implementation, and change adoption
• Ensure solutions address regulatory, quality, privacy, validation, documentation, and audit-trail requirements