Product Reviewer – Contractor

📋 Description

• Assess manufacturers' software lifecycle processes and technical documentation for medical device
• 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
• Identify, document, communicate, and follow up on technical assessment findings with manufacturers.
• Explain regulatory requirements and assessment findings clearly and constructively, both verbally
• Work with manufacturers to clarify technical issues and close out assessment findings.

🎯 Requirements

• Bachelor's degree or higher in Software Engineering, Computer Science, Electrical or Electronic
• At least 4 years of professional experience in the medical device industry or another
• At least 2 years of experience designing, developing, or testing safety-critical software.
• Previous experience as a Product Reviewer or technical documentation assessor for a notified body
• Working knowledge of IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, and medical device
• Practical understanding of software development fundamentals, including lifecycle processes

🎁 Benefits

• Fully remote contractor position.
• Flexible scheduling, depending on assessment demand and availability.
• Opportunity to work on innovative medical device software, including AI-enabled healthcare
• Exposure to international regulatory frameworks and technical standards, including EU MDR, UK MDR
• Opportunity to contribute to medical device safety and help manufacturers navigate complex
• Independent working environment with established assessment methodologies and workflows.