Product Reviewer – Contractor (Fully Remote)

Scarlet; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Scarlet is seeking a regulatory software assessors to evaluate manufacturers' software lifecycle processes and documentation for medical device software, including SaMD and AI-enabled devices, under EU MDR, UK MDR, and IEC standards. The role involves raising findings and guiding manufacturers on compliance, delivering high-quality assessments aligned with Scarlet's methodology and values.

The ideal candidate will work independently with flexible scheduling, providing clear, constructive

Qualifications

• Assess manufacturers' software lifecycle processes and technical documentation for medical device software, including SaMD and AI-enabled devices, under EU MDR, UK MDR, and relevant IEC standards.

Responsibilities

• Raise and close out technical assessment findings with manufacturers, explaining regulatory requirements clearly and constructively.

Job description

• Assess manufacturers' software lifecycle processes and technical documentation for medical device software, including SaMD and AI-enabled devices, under EU MDR, UK MDR, and relevant IEC standards.
• Raise and close out technical assessment findings with manufacturers, explaining regulatory requirements clearly and constructively.
• Deliver consistent, high-quality assessments that match Scarlet's methodology and values, working independently with flexible scheduling.