We are looking for an experienced Business Analyst with 3-5 years of experience, including at least 2 years in the Medical Device/MedTech domain, specifically supporting Regulatory Affairs and/or Clinical Affairs.
The candidate will analyze existing business processes, identify gaps and pain points, and recommend AI-enabled automation, workflow improvements, and digital transformation opportunities. Responsibilities include gathering business requirements, conducting stakeholder workshops, preparing process maps, user stories, acceptance criteria, and business cases, and collaborating with Regulatory, Clinical, Quality, IT, and AI teams.
Strong knowledge of medical device regulatory processes, quality systems, documentation controls, compliance, data privacy, and validation is essential.
Required Skills:
- Business Analysis (3-5 Years)
- MedTech / Medical Device Domain (2+ Years)
- Regulatory Affairs / Clinical Affairs
- AI & Intelligent Automation
- Business Requirements Gathering
- BRD, FRD, User Stories & Acceptance Criteria
- AS-IS / TO-BE Process Mapping
- Gap Analysis & Root Cause Analysis
- Workflow Automation & Digital Transformation
- Regulatory Compliance & Quality Systems
- Stakeholder Management & Workshops
- UAT, Traceability & Change Management
- MS Excel, PowerPoint, Visio
