Remote Medical Device Software Reviewer

Jobgether

Turkey

À distance

TRY 180 000 - 300 000

Plein temps

Il y a 2 jours
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Avantages offerts par ce poste

Fully remote contractor position
Flexible scheduling

Résumé du poste

Jobgether is seeking a Product Reviewer – Contractor based in Turkey to independently assess medical device software documentation, including SaMD and AI-enabled solutions. You will evaluate regulatory compliance with EU MDR and UK MDR, IEC standards, and provide clear, constructive feedback to manufacturers.

The role is fully remote with flexible scheduling. Ideal candidates will have 4+ years in medical device software and hands-on experience with software lifecycle processes and cybersecurity

Qualifications

  • Bachelor's degree or higher in a relevant discipline.
  • 4+ years in medical device industry or safety-critical sector.
  • 2+ years in designing, developing, or testing safety-critical software.
  • Experience as Product Reviewer or technical documentation assessor for notified/UK competent body.

Responsabilités

  • Independently deliver accurate, high-quality assessments of medical device software documentation.
  • Evaluate compliance with EU MDR, UK MDR, IEC 62304, IEC 82304-1, IEC 62366-1, IEC 81001-5-1.
  • Identify and follow up on technical assessment findings with manufacturers.
  • Explain regulatory requirements clearly, in writing and verbally.
  • Adopt established assessment workflows to ensure consistency and quality.

Connaissances

Regulatory knowledge
Technical documentation assessment
Independent working
Communications skills
SaMD expertise
AI/ML familiarity

Formation

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

Description du poste

Jobgether is seeking a Product Reviewer – Contractor based in Turkey to independently assess medical device software documentation, including SaMD and AI-enabled solutions. You will evaluate regulatory compliance with EU MDR and UK MDR, IEC standards, and provide clear, constructive feedback to manufacturers.

The role is fully remote with flexible scheduling. Ideal candidates will have 4+ years in medical device software and hands-on experience with software lifecycle processes and cybersecurity

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