Business Analyst - SEDHA CONSULTING PTE. LTD.

Roles & Responsibilities

a. The BA will support the development and regulatory readiness of Customer's digital health platform through two key workstreams.

b. In the first workstream, the BA will work closely with functional, clinical, and technical teams to support ongoing requirements gathering for new platform features and enhancements. This will involve engaging stakeholders to elicit and analyse needs, translating these into clear, testable, and traceable requirements, and documenting them in the appropriate formats, such as user stories, use cases, and acceptance criteria.

c. The BA will ensure that all requirements are aligned with user needs, regulatory considerations, and technical feasibility, while maintaining version control and keeping documentation up to date as features evolve. Deliverables from this workstream will include complete and accurate requirements documentation for all new features developed during the engagement, recorded in the Customer’s requirements management tools.

d. The second workstream will focus on improving Customer' existing requirements and related documentation to prepare for Quality Management System (QMS) certification and ISO 13485 submission.

e. The BA will review and refine the current set of platform requirements to ensure completeness, accuracy, and compliance with relevant standards. This will include standardising and improving documentation templates, processes, and traceability practices to meet QMS expectations.

f. The BA will develop and maintain a requirements traceability matrix linking requirements to design specifications, risk management records, and verification and validation outputs.

g. Deliverables will include a QMS-compliant and ISO 13485-ready requirements documentation set, updated requirements management processes and templates, and a complete and maintained requirements traceability matrix

Tell employers what skills you have

Version Control

Requirements Management

Requirements Gathering

UAT

Microsoft Excel

Quality Management

User Stories

Business Analysis

Translating

ISO

Risk Management

Traceability

SQL

Banking

Business Analyst

Business Requirements