Remote SaMD Regulatory Reviewer – Medical Device Software

Jobgether; Netherlands; Remote; EUR 83,000 - 138,000; Part time

Benefits offered by this job

Fully remote

Flexible scheduling

Innovative medical devices

International regulatory frameworks

Medical device safety

Independent work environment

Job summary

Jobgether is seeking a Product Reviewer – Contractor based in the Netherlands to assess medical device software documentation, including SaMD and AI-enabled solutions. You will evaluate compliance with EU MDR, UK MDR, and ISO/IEC standards, documenting findings and helping manufacturers address gaps.

This fully remote role offers flexible scheduling and autonomy in a diverse regulatory environment. Ideal candidates bring 4+ years in medical device software, strong regulatory knowledge, and

Qualifications

• Bachelor's degree or higher in software-related field.
• Minimum 4 years in medical device or safety-critical sector.
• At least 2 years designing, developing, or testing safety-critical software.
• Experience as Product Reviewer or software documentation assessor for notified/UK bodies.
• Knowledge of IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, and cybersecurity.
• Ability to interpret regulatory requirements when assessing software docs.
• Proven track record delivering high-quality assessments.
• Experience with SaMD.
• Strong written and verbal communication abilities.
• Ability to work independently with minimal supervision.

Responsibilities

• Deliver accurate, consistent technical assessments of medical device software documentation.
• Assess software lifecycle processes for SaMD and AI-enabled devices.
• Evaluate compliance with EU MDR, UK MDR, IEC 62304, IEC 82304-1, IEC 62366-1, IEC 81001-5-1.
• Review 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.
• Work with manufacturers to clarify issues and close findings.
• Deliver high-quality assessments using established methodologies.
• Adopt workflows and tools to ensure consistency and quality across reviews.

Skills

Regulatory knowledge

Technical writing

Independent judgment

Communication skills

Software lifecycle

SaMD experience

Safety-critical software

AI/ML familiarity

Education

Bachelor's degree

Software Engineering

Electrical Engineering

Job description

Jobgether is seeking a Product Reviewer – Contractor based in the Netherlands to assess medical device software documentation, including SaMD and AI-enabled solutions. You will evaluate compliance with EU MDR, UK MDR, and ISO/IEC standards, documenting findings and helping manufacturers address gaps.

This fully remote role offers flexible scheduling and autonomy in a diverse regulatory environment. Ideal candidates bring 4+ years in medical device software, strong regulatory knowledge, and