Product Reviewer – Contractor
Via agency · Jobgether
Field inspector
Software tester
Other engineerFlexibleTemporaryRemote
As a Product Reviewer, you will independently assess the technical documentation and software lifecycle processes of medical device software, including Software as a Medical Device (SaMD) and AI-enabled solutions. You will help ensure that innovative healthcare technologies meet rigorous regulatory, technical, and safety requirements. Working with manufacturers, you will evaluate compliance with European and UK medical device regulations and relevant international standards.
Tasks
- 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.