Remote SaMD Product Reviewer (Contractor)

Scarlet; Dubai Emirate; Hybrid; AED 304,000 - 557,000; Full time

Job summary

Scarlet is seeking a Product Reviewer – Contractor to independently deliver efficient, high-quality technical documentation assessments of medical device software, in line with Scarlet's standards and culture. The role is fully remote with flexible scheduling, suitable for reviewers authorized as a Product Reviewer for software under EU MDR and UK MDR.

You'll work with our assessment workflows, raise and close out findings, and deliver assessments that meet regulatory requirements and Scarlet's

Qualifications

• Bachelor's degree or higher in software engineering, computer science, electrical/electronic engineering or related field.
• At least 4 years in medical devices or safety-critical sector.
• Minimum 2 years designing, developing or testing safety-critical software.
• Experience as Product Reviewer for a notified body or UK approved body.
• Proficient in interpreting regulatory requirements for software documentation.
• Ability to deliver high-quality technical documentation assessments.

Responsibilities

• Assess software lifecycle processes and documentation for medical device software under EU MDR/UK MDR.
• Raise and close out technical assessment findings with manufacturers.
• Deliver consistent assessments aligned with Scarlet's methodology.

Skills

Regulatory interpretation

Technical writing

Independent work

Education

Bachelor's degree or higher in software engineering or related field

Tools

IEC 62304

IEC 82304-1

ISO 14971

IEC 62366-1

IEC 81001-5-1

Job description

Scarlet is seeking a Product Reviewer – Contractor to independently deliver efficient, high-quality technical documentation assessments of medical device software, in line with Scarlet's standards and culture. The role is fully remote with flexible scheduling, suitable for reviewers authorized as a Product Reviewer for software under EU MDR and UK MDR.

You'll work with our assessment workflows, raise and close out findings, and deliver assessments that meet regulatory requirements and Scarlet's