Proclinical is seeking a Software Quality Engineer to contribute to the development and maintenance of technical documentation and ensure compliance with global regulatory and quality standards for SaMD products, including AI-enabled software. This role involves collaborating with cross-functional teams to support software lifecycle processes, risk management, and audit readiness.
The role requires familiarity with IEC 62304, ISO 13485, FDA CFR 820-QMSR, ISO 14971, and the ability to translate
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📌 SaMD Quality Engineer: Regulatory Docs & Audits (Western Australia)
🏢 ProClinical
📍 Western Australia
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