Product Reviewer – Contractor

About the role:

• Independent contractor role delivering efficient, high-quality technical documentation assessments of medical device software.
• Fully remote with flexible scheduling, subject to assessment demand and availability.
• Suitable for reviewers already authorised as Product Reviewers under EU MDR and UK MDR.

Responsibilities:

• Assess software lifecycle processes and technical documentation for SaMD and AI-enabled devices under EU MDR, UK MDR, IEC 62304, IEC 82304-1, IEC 62366-1 and IEC 81001-5-1.
• Raise and close out findings with manufacturers, explaining requirements clearly and constructively.
• Deliver assessments consistently aligned with Scarlet's methodology and values.

Required qualifications:

• Bachelor's degree or higher in software engineering, computer science, electrical/electronic engineering or a closely related field, plus 4+ years in medical device or safety-critical sectors.
• Prior work as a Product Reviewer for a notified body or UK approved body covering software devices.
• Working knowledge of IEC 62304, ISO 14971, medical device cybersecurity, and software development fundamentals.

Preferred qualifications:

• Experience assessing AI/ML-enabled medical devices and practical generative AI experience.
• Familiarity with MDCG 2019-11 and MDCG 2020-1 guidance.

Interview process:

• Introductory call with Guni (20 minutes).
• Two product reviewer competence and regulatory interviews (30–45 minutes each).
• Offer and references.