Business Analyst - Regulatory & Clinical Affairs

Tata Consultancy Services; Santa Clara (CA); On-site; USD 75,000 - 83,000; Full time

Benefits offered by this job

Annual incentive

Medical coverage

Parental leave

Insurance options

Training reimbursement

Vacation & holidays

401K & bonuses

Job summary

Tata Consultancy Services Limited in Santa Clara, CA seeks a Business Analyst with 3-5 years of relevant experience, including 2+ years in medical device/MedTech regulatory/clinical support. You will map processes, define requirements, and identify AI-enabled automation opportunities while ensuring regulatory and quality compliance.

Collaborate with Regulatory Affairs, Clinical Affairs, Quality, IT, and data/privacy teams to drive impactful improvements, document traceability, and stakeholder

Qualifications

• 3-5 years of relevant Business Analyst experience, targeting ~5 years.
• 2+ years in medical device/MedTech sector supporting Regulatory/Clinical Affairs.
• Regulated medical device processes, quality systems, documentation controls, regulatory expectations.
• Identify pain points, gaps, manual effort, and opportunities for AI-enabled automation.
• Translate business needs into problem statements, requirements, user stories, acceptance criteria, and process maps.
• Experience with AI, automation, analytics, and digital transformation concepts.
• Evaluate solutions for regulatory, clinical, privacy, quality, validation, traceability, and change-management.
• Facilitate discovery workshops, stakeholder interviews, requirements reviews, and prioritization.
• Strong analytical skills: process mapping, gap analysis, root cause, data analysis, KPI definition.
• Proficiency with Excel, PowerPoint, Word, Visio or equivalent; experience with agile tools preferred.
• Excellent written and verbal communication across all levels.

Responsibilities

• Independently assess Regulatory Affairs and Clinical Affairs processes to understand objectives, workflows, data, controls, pain points and dependencies.
• Identify and evaluate AI, automation, analytics, and workflow-improvement opportunities based on value, feasibility, risk and regulatory impact.
• Develop concise opportunity statements, problem statements, business cases, process maps, requirements, user stories, acceptance criteria, and traceability docs.
• Partner with Regulatory Affairs, Clinical Affairs, Quality, IT, Data/AI, Privacy, Security and cross-functional stakeholders to validate needs and scope.
• Facilitate workshops/interviews with stakeholders from individual contributors to VP leadership and present findings clearly.
• Document current-state and future-state processes, rules, data flows, roles, handoffs, risks, assumptions and success measures.
• Prioritize use cases, support solution evaluation, backlog refinement, testing/UAT readiness, implementation planning and change adoption.
• Ensure solutions maintain regulatory, clinical, privacy, validation, documentation and audit-trail considerations.
• Prepare executive-ready summaries, presentations, dashboards and recommendations for timely decisions.
• Drive assigned work independently within the contract timeline and escalate risks promptly.

Skills

Business analysis

Regulatory affairs

AI & automation

Process mapping

Data analysis

Stakeholder management

Education

Bachelor of Business Information Systems

Tools

Visio

Microsoft Excel

MS Office

Job description

Job Description

Must Have Technical/Functional Skills

• 3-5 years of relevant Business Analyst experience, with a target of approximately 5 years.
• Minimum 2 years of experience in the medical device/MedTech sector, specifically supporting Regulatory Affairs and/or Clinical Affairs processes.
• Strong understanding of regulated medical device business processes, quality systems, documentation controls, and applicable regulatory expectations.
• Ability to independently assess current-state workflows, identify pain points, control gaps, manual effort, and opportunities for AI-enabled automation.
• Experience translating business needs into clear problem statements, business requirements, functional requirements, user stories, acceptance criteria, and process maps.
• Working knowledge of AI, intelligent automation, workflow automation, analytics, and digital transformation concepts, including identification of appropriate use cases and business value.
• Ability to evaluate proposed solutions for regulatory, clinical, data privacy, quality, validation, traceability, and change-management considerations.
• Experience facilitating discovery workshops, stakeholder interviews, requirements reviews, and prioritization sessions.
• Strong analytical skills with proficiency in process mapping, gap analysis, root cause analysis, data analysis, and KPI definition.
• Proficiency with Microsoft Office tools, including Excel, PowerPoint, Word, Visio or equivalent process-mapping tools; experience with requirements or agile tools is preferred.
• Excellent written and verbal communication skills, with the ability to engage stakeholders from individual contributors through VP-level leadership.

Roles & Responsibilities

• Independently assess Regulatory Affairs and Clinical Affairs business processes to understand objectives, workflows, systems, data, controls, pain points, and dependencies.
• Identify and evaluate AI, automation, analytics, and workflow-improvement opportunities based on business value, feasibility, risk, and regulatory impact.
• Develop concise opportunity statements, problem statements, business cases, process maps, requirements, user stories, acceptance criteria, and traceability documentation.
• Partner with Regulatory Affairs, Clinical Affairs, Quality, IT, Data/AI, Privacy, Security, and other cross-functional stakeholders to validate needs and align on solution scope.
• Facilitate workshops and interviews with stakeholders at all levels, from individual contributors to VP leadership, and communicate findings in a clear, decision-oriented format.
• Document current-state and future-state processes, business rules, data flows, roles, handoffs, risks, assumptions, and success measures.
• Prioritize use cases and requirements; support solution evaluation, backlog refinement, testing/UAT readiness, implementation planning, and change adoption.
• Ensure proposed solutions maintain appropriate regulatory, clinical, quality, privacy, validation, documentation, and audit-trail considerations.
• Prepare executive-ready summaries, presentations, dashboards, and recommendations that enable timely decisions.
• Drive assigned work independently within the short-term contract timeline and elevate decisions, risks, and dependencies promptly.

Salary Range: $75,000-$83,000 a year

TCS Employee Benefits Summary

• Discretionary Annual I ncentive.
• Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
• Family Support: Maternal & Parental Leaves.
• Insurance Options: Auto & Home Insurance, Identity Theft Protection.
• Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.
• Time Off: Vacation, Time Off, Sick Leave & Holidays.
• Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.

#LI-SP1

Location: Santa Clara, CA

Function: TECHNOLOGY

Role: Business Analyst

ID: 435670

Skills: Business analyst | Medical Device NPD

Salary Range: $75,000 - $83,000

Desired Candidate Profile

Qualifications

Bachelor of Business Information Systems