Remote Product Reviewer: MedTech Software Compliance

Jobgether; Norway; Remote; NOK 781,000 - 1,228,000; Part time

Benefits offered by this job

Fully remote contractor position

Flexible scheduling

Job summary

Jobgether is seeking a Product Reviewer contractor based in Norway to independently assess medical device software documentation, including SaMD and AI-enabled solutions. You will evaluate compliance with EU MDR and UK MDR, IEC standards, and communicate findings clearly to manufacturers.

You will work remotely with flexible scheduling, supporting developers to meet regulatory and safety requirements while contributing to faster certification of innovative healthcare technologies.

Qualifications

• Bachelor's degree or higher in a software/engineering field.
• At least 4 years in the 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 approved body.
• Knowledge of IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, and medical device cybersecurity requirements.
• Ability to interpret and apply regulatory requirements in software documentation.
• Proven track record delivering high-quality technical assessments.
• Experience with SaMD.
• Strong written and verbal communication skills.
• Ability to manage assessments independently.

Responsibilities

• Deliver accurate, consistent technical assessments of medical device software documentation.
• 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 for regulatory compliance.
• Identify and communicate assessment findings with manufacturers.
• Explain regulatory requirements clearly in writing and verbally.
• Work with manufacturers to close out assessment findings.
• Deliver high-quality assessments using established methodologies.
• Apply independent judgment with minimal supervision.
• Adopt established workflows and tools for consistency.

Skills

Regulatory knowledge

Technical assessment

SaMD experience

Independent work

Regulatory communication

Education

Bachelor's degree in Software Engineering

Bachelor's degree in Computer Science

Job description

Jobgether is seeking a Product Reviewer contractor based in Norway to independently assess medical device software documentation, including SaMD and AI-enabled solutions. You will evaluate compliance with EU MDR and UK MDR, IEC standards, and communicate findings clearly to manufacturers.

You will work remotely with flexible scheduling, supporting developers to meet regulatory and safety requirements while contributing to faster certification of innovative healthcare technologies.