Remote Medical Device Software Assessor

Jobgether; Canada; Remote; CAD 90,000 - 130,000; Part time

Benefits offered by this job

Fully remote contractor

Flexible scheduling

Exposure to AI-enabled medical devices

Job summary

Jobgether is seeking a Product Reviewer – Contractor based in Canada to independently assess medical device software documentation, including SaMD and AI-enabled devices. The role focuses on regulatory compliance with EU MDR, UK MDR, and relevant IEC standards, communicating findings to manufacturers, and supporting remediation of gaps.

The position is fully remote with flexible scheduling, offering exposure to international regulatory frameworks and advanced healthcare technologies.

Qualifications

• Bachelor's degree or higher in software/engineering discipline is required.
• Experience in medical device software regulatory frameworks is desired.

Responsibilities

• Independently deliver accurate, high-quality technical assessments of medical device software documentation.
• Evaluate compliance with EU MDR, UK MDR, IEC 62304, IEC 82304-1, IEC 62366-1, IEC 81001-5-1.
• Identify, document, and communicate findings with manufacturers.
• Explain regulatory requirements clearly, both verbally and in writing.
• Work with manufacturers to close out assessment findings.
• Apply independent judgment with minimal supervision.

Education

Bachelor's degree or higher in Software Engineering, Computer Science, Electrical or Electronic Engineering, or closely related discipline

Job description

Jobgether is seeking a Product Reviewer – Contractor based in Canada to independently assess medical device software documentation, including SaMD and AI-enabled devices. The role focuses on regulatory compliance with EU MDR, UK MDR, and relevant IEC standards, communicating findings to manufacturers, and supporting remediation of gaps.

The position is fully remote with flexible scheduling, offering exposure to international regulatory frameworks and advanced healthcare technologies.