Remote SaMD & AI Software Reviewer (Contractor)

Jobgether; México; Remoto; MXN 648.000 - 1.038.000; Part-time

Vantaggi offerti da questo lavoro

Fully remote contractor position

Flexible scheduling

Exposure to international regulatorys

Descrizione del lavoro

Jobgether in Mexico is seeking a Product Reviewer contractor to independently assess medical device software and AI-enabled solutions for regulatory compliance, including EU/UK MDR and ISO standards.

The role emphasizes independent work, clear communication of findings, and adherence to established assessment workflows, enabling manufacturers to resolve gaps while ensuring patient safety and rapid certification.

Competenze

• Bachelor's degree or higher in Software Engineering, Computer Science, Electrical or Electronic Engineering, or related field.
• Minimum 4 years in medical device or safety-critical industries.
• At least 2 years designing or testing safety-critical software.
• Experience as Product Reviewer or documentation assessor for a notified body or UK approved body (software devices).
• Knowledge of IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, and cybersecurity requirements (IEC 81001-5-1, MDCG).
• Understanding of software development fundamentals, lifecycle processes, verification and validation, configuration management, and cybersecurity.
• Experience assessing SaMD.
• Strong written and verbal communication skills.
• Ability to work independently and apply regulatory requirements to software documentation.
• Willingness to adopt established assessment methodologies and workflows.

Mansioni

• Assess manufacturers' software lifecycle processes and technical documentation for medical device software, including SaMD and AI-enabled devices.
• Evaluate compliance with EU MDR, UK MDR, IEC 62304, IEC 82304-1, IEC 62366-1, and IEC 81001-5-1.
• Review software development and lifecycle documentation to verify regulatory and technical requirements are met.
• Identify, document, communicate, and follow up on technical assessment findings with manufacturers.
• Explain regulatory requirements and assessment findings clearly, both verbally and in writing.
• Work with manufacturers to clarify technical issues and close out assessment findings.
• Deliver consistent, efficient, and high-quality assessments in line with methodologies and values.
• Apply independent judgment when evaluating technical documentation and regulatory compliance.
• Adopt established assessment workflows to ensure consistency and quality across reviews.

Conoscenze

Regulatory assessment

Technical writing

Communicate findings

Independent judgment

AI/ML in healthcare

Formazione

Bachelor's degree or higher in Software/CS/EE

Descrizione del lavoro

Jobgether in Mexico is seeking a Product Reviewer contractor to independently assess medical device software and AI-enabled solutions for regulatory compliance, including EU/UK MDR and ISO standards.

The role emphasizes independent work, clear communication of findings, and adherence to established assessment workflows, enabling manufacturers to resolve gaps while ensuring patient safety and rapid certification.