Job Summary

As a member of the Global IT Function, you as Business Analyst plays a critical role in identifying, designing, and delivering technology solutions that optimize business processes across Medical, Quality, Regulatory, Supply Chain functions within a medical device organization. This role bridges business strategy, data science and technology execution, ensuring technology initiatives are compliant, scalable and aligned with the company s digital transformation roadmap and regulatory requirements Food and Drug Administration (FDA), ISO 13485, Good "X" Practice (GxP).

This individual partners closely with cross-functional teams to translate complex business problems into a configurable solution, define data and process requirements, support solution development, manage validation needs and measure impact.

What You'll Be Doing

- 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), 21 Code of Federal Regulations (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 Bring

- 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 workplace.

- 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.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

Role: Technical Lead,

Industry Type: Pharmaceutical & Life Sciences,

Department: Engineering - Software & QA,

Employment Type: Full Time, Permanent

Role Category: Software Development

Education

UG: B.Tech / B.E. in Any Specialization, Any Graduate

PG: Any Postgraduate

Key Skills administrationaianalyticsautomationbusiness analystbusiness strategycfrcode of federal regulationsdata analystdata analyticsdata sciencedigital transformationgamphealthcareinformation technologyintegrationsiso 13485

📌 Analyst, Information Technology (Bengaluru)
🏢 BAXTER
📍 Bengaluru