Product Reviewer – Contractor

Stack

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Descrizione

Accountabilities - In this role, you will independently deliver accurate, consistent, and high-quality technical assessments of medical device software documentation. Your responsibilities will include: Assess manufacturers' software lifecycle processes and technical documentation for medical device software, including SaMD and AI-enabled devices. - Evaluate compliance with EU MDR, UK MDR, IEC 62304, IEC 82304-1, IEC 62366-1, and IEC 81001-5-1. - Review software development and lifecycle documentation to verify that applicable regulatory and technical requirements are met. - Identify, document, communicate, and follow up on technical assessment findings with manufacturers. - Explain regulatory requirements and assessment findings clearly and constructively, both verbally and in writing. - Work with manufacturers to clarify technical issues and close out assessment findings. - Deliver consistent, efficient, and high-quality assessments in accordance with established methodologies, standards, and values. - Apply independent judgment when evaluating technical documentation and regulatory compliance, with minimal supervision. - Adopt established assessment workflows, tools, and working practices to ensure consistency and quality across reviews. - Requirements The ideal candidate will have established experience assessing medical device software, a strong understanding of regulatory frameworks, and the ability to deliver independent technical reviews. Required qualifications inclu

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