Analyst, Information Technology

Overview

As a Business Analyst in the Global IT Function, you will identify, design and deliver technology solutions that optimize business processes across Medical, Quality, Regulatory and Supply Chain functions within a medical device organization, ensuring compliance with FDA, ISO 13485 and GxP requirements.

What you'll do

• Partner with business leaders to identify high-value improvement opportunities in areas such as regulatory affairs, patient safety, process optimization, product quality, complaint analytics and regulatory intelligence.
• Conduct feasibility assessments and prioritization of user stories.
• Stay current on emerging regulatory developments and industry best practices within regulated healthcare environments.
• Lead detailed discovery sessions to understand business workflows, data sources, constraints and pain points.
• Translate business needs into clear functional requirements for technical and vendor partners.
• Map current-state and future-state processes to identify automation and optimization opportunities.
• Review and analyze user requirements prior to submission and implementation; participate in validation activities as required.
• Ensure solutions comply with company Quality Management Systems (QMS) requirements, Good Automated Manufacturing Practice (GAMP 5), and 21 CFR Part 11 regulations.
• Support the creation, review, and execution of validation deliverables, including Validation Plans, Risk Assessments, Risk Management Reports, Traceability Matrices, Validation Reports, User Acceptance Testing (UAT), and Regression Testing activities.
• Partner with QA / RA / Business teams to implement configuration and perform validation execution.
• Develop user stories, Formal Requirements, UAT scripts, test cases, test plans and training materials.
• Lead UAT cycles, gather feedback and ensure readiness for go-live.
• Drive adoption through ongoing user engagement, training and performance monitoring.
• Understand, follow and implement appropriate Software Development Life Cycle (SDLC), computer system validation, quality validation processes and application lifecycle processes, including those specific to AI project lifecycles.

What you'll need

• Bachelor's degree in Engineering, Computer Science, Data Analytics or related field.
• 6–10+ years of experience as a Business Analyst, Product Owner, Data Analyst or similar role.
• Experience working in a regulated life science, medical device, pharmaceutical, or healthcare environment.
• Experience working with validation, implementation of GxP applications such as Veeva RIM, Veeva PromoMats, Patient Safety, Medical Systems.
• Strong understanding of computer system validation, computer system assurance processes, analytics workflows and system integrations.
• Ability to translate complex business needs into structured requirements and user stories.
• Excellent communication, facilitation and stakeholder management skills.
• Familiarity with GxP, GAMP 5, 21 CFR Part 11, ISO 13485 and validation principles.

Details

• Location: Bangalore, Karnataka.