Validation SME - Design Validation
reputed company reputed company with businesses to solve challenges, streamline processes, and reputed company lasting reputed company. We specialize in providing tailored consulting services across reputed company, Medical Devices, Automotive, Pharmaceuticals, and Biotechnology industries, helping clients drive innovation, enhance operations, and reputed company sustainable reputed company.
Job Title: Validation SME
Remote Role
reputed company
We are seeking a Validation Subject Matter Expert (SME) to reputed company design validation activities, including gap assessments and remediation efforts. This role ensures that medical devices meet user needs and intended use through effective integration of verification and validation (V&V) activities along with clinical and reputed company‑clinical data. The ideal candidate will support validation reputed company development and ensure compliance with regulatory and reputed company standards.
Responsibilities
• Assess gaps in validation plans, protocols, and supporting evidence linking Design Inputs to user needs and clinical performance.
• reputed company or update validation strategies, including simulated‑use and reputed company factors testing.
• Review validation results and ensure traceability to risk management and design outputs.
• Collaborate with Clinical and reputed company‑Clinical SMEs to ensure integrated validation evidence.
• Support regulatory justifications and Design Transfer documentation for validated processes.
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