MedTech Software Reviewer — Remote Contractor

Jobgether; Schweiz; Remote; CHF 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Fully remote contractor position

Flexible scheduling

Zusammenfassung

Jobgether is seeking a Product Reviewer – Contractor based in Switzerland to independently assess medical device software, SaMD, and AI-enabled solutions, ensuring compliance with EU MDR, UK MDR, IEC standards, and cybersecurity requirements. You will communicate findings to manufacturers, apply established workflows, and deliver high-quality assessments with minimal supervision in a fully remote setup.

A background in software engineering and at least 4 years in medical device safety-critical

Qualifikationen

• Bachelor's degree or higher in a software/engineering discipline.
• 4+ years in medical device or safety-critical industries.
• Experience as Product Reviewer or technical documentation assessor preferred.

Aufgaben

• Assess medical device software and SaMD documentation for regulatory and technical compliance.
• Evaluate alignment with EU MDR, UK MDR, IEC 62304, 82304-1, 62366-1, and 81001-5-1.
• Identify and document regulatory findings; communicate them clearly to manufacturers.

Kenntnisse

Software Engineering

Regulatory knowledge

SaMD

AI/ML familiarity

Communication skills

Independent work

Lifecycle processes

Ausbildung

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

Jobbeschreibung

Jobgether is seeking a Product Reviewer – Contractor based in Switzerland to independently assess medical device software, SaMD, and AI-enabled solutions, ensuring compliance with EU MDR, UK MDR, IEC standards, and cybersecurity requirements. You will communicate findings to manufacturers, apply established workflows, and deliver high-quality assessments with minimal supervision in a fully remote setup.

A background in software engineering and at least 4 years in medical device safety-critical