New 
Business Analyst - Regulatory & Clinical Affairs
 Tata Consultancy Services | |
$75,000 - $83,000
| |
sick time, 401(k)
| |
 United States, California, Santa Clara | |
 Oct 28, 2026 | |
|
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 escalate 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 | |