Regulatory & Clinical AI Analyst (Automation)
Siri InfoSolutions Inc
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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
Tools
Job description
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
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