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SiMD Biness Analyst

Persolkelly India

Posted On: 2025-12-26 21:14:51
Openings: 10
Applicants: 0

Job Description

The SiMD Business Analyst will support the development, implementation, and management of Software in Medical Devices systems, ensuring end-to-end alignment between business requirements, regulatory expectations, and technical solutions. The role involves requirement gathering, documentation, validation support, stakeholder collaboration, and compliance with medical device standards.

Responsibilities:

Lead requirements elicitation, analysis, prioritization, and documentation for SiMD initiatives.
Create and maintain functional documentation including BRD, FRS, User Stories, and Process Flows.
Ensure compliance with regulatory frameworks applicable to Software in Medical Devices.
Collaborate with engineering, QA, compliance, and business stakeholders to support solution design and product delivery.
Support testing, validation, and UAT cycles including traceability mapping and defect review.
Participate in release planning, change management, and continuous improvement initiatives.

Required Skills & Experience:

Minimum 8+ years experience as a Business Analyst in Medical Devices/Healthcare IT.
Strong understanding of regulated SDLC, GxP practices, validation, and documentation standards.
Experience working with Agile methodologies and requirement management tools (e.g., Azure DevOps, JIRA).
Excellent communication, analytical thinking, and stakeholder management skills.