MedTech SaMD Product Reviewer - Remote Contractor

Jobgether; España; Remoto; EUR 96.000 - 165.000; Part-time

Vantaggi offerti da questo lavoro

Fully remote contract

Flexible scheduling

Exposure to AI-enabled healthcare tech

International regulatory exposure

Descrizione del lavoro

Jobgether is seeking a Product Reviewer (Contractor) based in Spain to independently assess medical device software documentation, including SaMD and AI-enabled solutions.

You will evaluate compliance with EU MDR, UK MDR, IEC 62304, IEC 82304-1, IEC 62366-1, and related standards, identify gaps, and clearly communicate findings to manufacturers while supporting remediation efforts. This fully remote role offers flexible scheduling.

Competenze

• Bachelor's degree or higher in software/engineering.
• 4+ years in the medical device industry or safety-critical sector.
• 2+ years designing, developing, or testing safety-critical software.
• Experience as Product Reviewer or documentation assessor for notified/UK bodies.
• Experience with IEC 62304, 82304-1, ISO 14971, 62366-1, cybersecurity.

Mansioni

• Assess medical device software documentation for SaMD and AI-enabled devices.
• Evaluate compliance with EU MDR, UK MDR, IEC 62304, IEC 82304-1.
• Identify and communicate regulatory gaps to manufacturers.
• Apply established assessment workflows with minimal supervision.
• Explain regulatory requirements clearly in writing and verbally.

Conoscenze

Regulatory knowledge

Technical assessment

Software lifecycle

Medical devices

AI in healthcare

Formazione

Software engineering degree

Descrizione del lavoro

Jobgether is seeking a Product Reviewer (Contractor) based in Spain to independently assess medical device software documentation, including SaMD and AI-enabled solutions.

You will evaluate compliance with EU MDR, UK MDR, IEC 62304, IEC 82304-1, IEC 62366-1, and related standards, identify gaps, and clearly communicate findings to manufacturers while supporting remediation efforts. This fully remote role offers flexible scheduling.