Remote Medical Device Software Reviewer (Finland)

Jobgether; Finland; Remote; EUR 78,000 - 123,000; Full time

Benefits offered by this job

Fully remote contractor position

Flexible scheduling

Exposure to international regulatory fi

AI-enabled healthcare tech projects

Job summary

Jobgether invites a Product Reviewer – Contractor based in Finland to independently assess medical device software documentation and lifecycle processes, including SaMD and AI-enabled devices. You will ensure compliance with EU/UK MDR and essential IEC standards, communicating findings to manufacturers to close regulatory gaps.

The role is fully remote with flexible scheduling, offering opportunities to influence safety and certification pathways for innovative healthcare technologies.

Qualifications

• Bachelor's degree or higher in Software Engineering, Computer Science, Electrical or Electronic Engineering, or a closely related discipline.
• 4+ years in medical device software or safety-critical sector.
• 2+ years designing, developing, or testing safety-critical software.
• Experience as Product Reviewer or technical documentation assessor for notified/UK bodies.
• Knowledge of IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, and cybersecurity requirements.

Responsibilities

• Independently assess medical device software documentation and lifecycle processes.
• Evaluate compliance with EU MDR, UK MDR, and applicable IEC standards.
• Identify, document, and communicate assessment findings to manufacturers.
• Explain regulatory requirements clearly in writing and verbally.
• Work with manufacturers to address technical issues and close findings.
• Deliver high-quality assessments using established workflows and tools.
• Apply independent judgment with minimal supervision.

Skills

Regulatory knowledge

Technical writing

Independent judgment

Regulatory communication

Software lifecycle

Education

Bachelor's degree or higher in Software Engineering / Computer Science / Electrical or Electronic Engineering

Job description

Jobgether invites a Product Reviewer – Contractor based in Finland to independently assess medical device software documentation and lifecycle processes, including SaMD and AI-enabled devices. You will ensure compliance with EU/UK MDR and essential IEC standards, communicating findings to manufacturers to close regulatory gaps.

The role is fully remote with flexible scheduling, offering opportunities to influence safety and certification pathways for innovative healthcare technologies.