MedTech Business Analyst: AI Automation & Compliance

Veriipro; Santa Clara (CA); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Veriipro is seeking an experienced Business Analyst specialized in Regulatory Affairs and Clinical Affairs in the medical device/MedTech sector. The role focuses on analyzing current processes, gathering requirements, and driving AI-enabled automation to enhance efficiency while ensuring regulatory compliance.

You will collaborate with cross-functional teams to map processes, define user stories and acceptance criteria, and support solution planning and change adoption.

Qualifikationen

• 3–5 years of Business Analyst experience in a regulated industry.
• Experience supporting Regulatory Affairs and/or Clinical Affairs in medical devices/MedTech.
• Strong understanding of regulated medical device processes, quality systems and regulatory requirements.
• Experience gathering requirements, documenting functional requirements, user stories and acceptance criteria.
• Knowledge of AI, intelligent automation, workflow automation and digital transformation.

Aufgaben

• Analyze current-state Regulatory Affairs and Clinical Affairs workflows, systems, data, controls, and processes.
• Identify opportunities for AI-enabled automation and digital transformation.
• Develop business requirements, functional requirements, user stories and acceptance criteria.
• Conduct stakeholder interviews, discovery workshops and requirements reviews.
• Perform gap analysis, root cause analysis, and data analysis to identify improvements.
• Collaborate with Regulatory Affairs, Clinical Affairs, Quality, IT, Data/AI, Privacy and Security teams.
• Document current and future-state workflows, data flows, and risks.

Kenntnisse

Regulatory Affairs

Clinical Affairs

Business Analysis

Requirements Gathering

Process Mapping

AI & Automation

Data Analysis

KPI Definition

Stakeholder Engagement

Tools

Excel

PowerPoint

Word

Visio

Jobbeschreibung

Veriipro is seeking an experienced Business Analyst specialized in Regulatory Affairs and Clinical Affairs in the medical device/MedTech sector. The role focuses on analyzing current processes, gathering requirements, and driving AI-enabled automation to enhance efficiency while ensuring regulatory compliance.

You will collaborate with cross-functional teams to map processes, define user stories and acceptance criteria, and support solution planning and change adoption.