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Job Description
Structured overview of role & requirementsAbout This Role
Lead software quality review and validation activities ensuring compliance with FDA, ISO, and IEC 62304 standards across the software development lifecycle.
Develop, review, and approve key validation deliverables such as test plans, validation protocols, traceability matrices, and reports.
Support risk assessments, change management, defect investigations, and audit readiness for FDA and ISO regulatory inspections.
Minimum Requirements
Bachelor’s degree in Computer Science, Computer Engineering, or related field.
Minimum 5 years of software validation and quality experience in regulated environments, medical device experience preferred.
Strong knowledge of regulatory standards including FDA regulations, IEC 62304, GAMP 5, and 21 CFR Part 11.
Location: Bengaluru; Work mode: Hybrid (2 days WFH, 3 days WFO).
Ideal Candidate Profile
Experienced in regulated software quality assurance specifically in medical device or similarly regulated domains.
Demonstrated expertise in software V&V, risk management (ISO 14971), and change management across cross-functional teams.
Capable of operational ownership of end-to-end compliance, audit readiness, and validation documentation in complex software systems including embedded and cloud-based platforms.