Regulatory Reviewer - Medical Device Software (SaMD)

Scarlet; United States; Teletrabalho; USD 90 000 - 130 000; Tempo integral

Resumo da oferta

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

Qualificações

• 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.

Responsabilidades

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

Descrição da oferta de emprego

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