AI-Enhanced SaMD Compliance Reviewer (Remote)

Jobgether; United Arab Emirates; Remote; AED 90,000 - 130,000; Full time

Benefits offered by this job

Fully remote contract

Flexible scheduling

Exposure to international regulatory**

Job summary

Jobgether seeks a Product Reviewer contractor based in the United Arab Emirates to independently assess medical device software documentation, including SaMD and AI-enabled devices, for regulatory and technical compliance under EU MDR and UK MDR. You will communicate findings to manufacturers and support remediation while adhering to established methodologies.

The role involves evaluating lifecycle processes, reviewing documentation, and delivering high-quality assessments with minimal

Qualifications

• Bachelor's degree or higher in a software/engineering-related discipline.
• At least 4 years in medical device industry or safety-critical sector.
• At least 2 years designing, developing, or testing safety-critical software.
• Experience as a Product Reviewer or documentation assessor for a notified body or UK body.
• Working knowledge of IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, and cybersecurity requirements.
• Ability to interpret regulatory requirements when assessing software documentation.
• Proven track record of delivering high-quality technical assessments.
• Experience with SaMD.
• Strong written and verbal communication skills.
• Ability to work independently with minimal oversight.
• Willingness to adopt established methodologies and tools.

Responsibilities

• Independently deliver accurate, high-quality technical assessments of medical device software documentation.
• Evaluate compliance with EU MDR, UK MDR, and relevant IEC standards.
• Review software lifecycle documentation to verify regulatory and technical requirements are met.
• Identify, document, and follow up on assessment findings with manufacturers.
• Explain regulatory requirements clearly, both verbally and in writing.
• Collaborate with manufacturers to clarify issues and close out findings.
• Deliver assessments consistently per established methodologies and values.
• Apply independent judgment with minimal supervision.
• Adopt established assessment workflows and tools.

Skills

Regulatory knowledge and compliance

Technical assessment

Software lifecycle understanding

SaMD experience

Communication skills

Independent work

AI/ ML familiarity

Education

Bachelor's degree in Software Engineering/CS/EE or related

Job description

Jobgether seeks a Product Reviewer contractor based in the United Arab Emirates to independently assess medical device software documentation, including SaMD and AI-enabled devices, for regulatory and technical compliance under EU MDR and UK MDR. You will communicate findings to manufacturers and support remediation while adhering to established methodologies.

The role involves evaluating lifecycle processes, reviewing documentation, and delivering high-quality assessments with minimal