Remote Medical Device Software Reviewer (Contractor)

Jobgether; Denmark; Remote; DKK 900,000 - 1,100,000; Part time

Benefits offered by this job

Fully remote contract

Flexible scheduling

Work on AI-enabled medical devices

Job summary

Jobgether, on behalf of a partner company, seeks a Product Reviewer – Contractor based in Denmark. You will independently assess medical device software documentation and lifecycle processes, including SaMD and AI-enabled solutions, ensuring compliance with EU MDR, UK MDR, IEC 62304, IEC 82304-1, IEC 62366-1, and IEC 81001-5-1.

This fully remote role offers flexible scheduling and the chance to work with manufacturers and international standards.

Qualifications

• Bachelor's degree or higher in software/engineering.
• 4+ years in medical device or safety-critical sector.
• 2+ years designing/testing safety-critical software.
• Experience as reviewer for notified/UK bodies on SaMD.
• Knowledge of IEC 62304, IEC 82304-1, ISO 14971 and related standards.
• Strong ability to interpret regulatory requirements in tech docs.

Responsibilities

• Assess software lifecycle processes and tech docs for medical device software (SaMD/AI).
• Evaluate compliance with EU/UK MDR and IEC standards.
• Identify and document regulatory gaps; communicate findings clearly.
• Collaborate with manufacturers to close issues and clarify requirements.
• Deliver high-quality assessments per established methodologies.

Skills

Medical device software

Regulatory knowledge

Independent reviewer

AI/ML familiarity

Communication skills

Education

BSc Software Engineering

MSc in related field

Job description

Jobgether, on behalf of a partner company, seeks a Product Reviewer – Contractor based in Denmark. You will independently assess medical device software documentation and lifecycle processes, including SaMD and AI-enabled solutions, ensuring compliance with EU MDR, UK MDR, IEC 62304, IEC 82304-1, IEC 62366-1, and IEC 81001-5-1.

This fully remote role offers flexible scheduling and the chance to work with manufacturers and international standards.