Business Analyst

Veriipro; Santa Clara (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory Affairs

Clinical Affairs

Business Analysis

Requirements Gathering

Process Mapping

AI & Automation

Data Analysis

KPI Definition

Stakeholder Engagement

Tools

Excel

PowerPoint

Word

Visio

Job description

We are seeking an experienced Business Analyst with expertise in Regulatory Affairs and Clinical Affairs within the medical device/MedTech industry. The ideal candidate will analyze business processes, identify opportunities for AI-enabled automation and digital transformation, gather requirements, and collaborate with cross-functional stakeholders to improve operational efficiency while maintaining regulatory compliance.

Key Responsibilities

• Analyze current-state Regulatory Affairs and Clinical Affairs workflows, systems, data, controls, and business processes.
• Identify opportunities for AI, intelligent automation, workflow automation, analytics, and digital transformation.
• Develop business requirements, functional requirements, user stories, acceptance criteria, process maps, and business cases.
• Conduct stakeholder interviews, discovery workshops, requirements reviews, and prioritization sessions.
• Perform gap analysis, root cause analysis, process mapping, and data analysis to identify improvement opportunities.
• Collaborate with Regulatory Affairs, Clinical Affairs, Quality, IT, Data/AI, Privacy, and Security teams.
• Document current-state and future-state workflows, business rules, data flows, dependencies, risks, and success metrics.
• Assess proposed solutions for regulatory compliance, data privacy, quality, validation, traceability, and change-management requirements.
• Support solution evaluation, backlog refinement, UAT readiness, implementation planning, and change adoption.
• Prepare executive presentations, reports, dashboards, and recommendations for senior leadership.
• Manage assigned deliverables independently and proactively communicate risks, decisions, and dependencies.

Required Skills and Qualifications

• 3–5 years of relevant Business Analyst experience, with approximately 5 years preferred.
• Minimum 2 years of experience in the medical device/MedTech industry, supporting Regulatory Affairs and/or Clinical Affairs.
• Strong understanding of regulated medical device processes, quality management systems, documentation controls, and regulatory requirements.
• Experience in business requirements gathering, functional requirements documentation, user stories, acceptance criteria, and process mapping.
• Knowledge of AI, intelligent automation, workflow automation, analytics, and digital transformation.
• Experience with process mapping, gap analysis, root cause analysis, data analysis, and KPI definition.
• Ability to identify automation opportunities and evaluate business value, feasibility, and regulatory impact.
• Proficiency in Microsoft Excel, PowerPoint, Word, Visio, or equivalent process-mapping tools.
• Experience with Agile methodologies and requirements management tools is preferred.
• Excellent written and verbal communication skills, with the ability to engage stakeholders from individual contributors to VP-level leadership.