Remote SaMD Reviewer — Regulatory Certification Expert

Scarlet; United States; À distance; USD 83 000 - 165 000; Plein temps

Résumé du poste

Scarlet seeks a remote Product Reviewer (Contractor) to independently assess medical device software documentation under EU MDR/UK MDR and IEC standards. You will review lifecycle processes and technical docs for SaMD and AI-enabled devices, raising findings and guiding manufacturers to meet requirements with Scarlet's proven approach.

The role offers flexible scheduling, requires 4+ years in safety-critical software and prior reviewer experience, and emphasizes clear written and verbal

Qualifications

• Bachelor's degree or higher in software/engineering field.
• 4+ years in medical device industry or safety-critical sector.
• 2+ years designing, developing or testing safety-critical software.
• Experience as Product Reviewer for a notified body or UK approved body (software devices).
• Knowledge of IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, IEC 81001-5-1.

Responsabilités

• Assess software life cycle processes and technical documentation for medical device software (SaMD/AI-enabled).
• Raise and close out technical assessment findings with manufacturers, with clear requirements.
• Deliver consistent, high-quality assessments that align with Scarlet's methodology.

Connaissances

Regulatory compliance knowledge

Technical documentation assessment

Independent work

Communication skills

Formation

Bachelor's degree or higher in software/engineering field

Outils

IEC 62304

ISO 14971

IEC 82304-1

Description du poste

Scarlet seeks a remote Product Reviewer (Contractor) to independently assess medical device software documentation under EU MDR/UK MDR and IEC standards. You will review lifecycle processes and technical docs for SaMD and AI-enabled devices, raising findings and guiding manufacturers to meet requirements with Scarlet's proven approach.

The role offers flexible scheduling, requires 4+ years in safety-critical software and prior reviewer experience, and emphasizes clear written and verbal