Scarlet Product Reviewer – Contractor at Scarlet independently assesses technical documentation for medical device software under EU and UK MDR standards. Ensures high-quality, consistent assessments aligned with Scarlet's methodology.
Responsibilities
The Product Reviewer – Contractor independently delivers efficient, high-quality technical documentation assessments of medical device software, in line with Scarlet's standards, approach and culture.
We are expanding our pool of product reviewers with contractor reviewers. This role suits reviewers who already meet the criteria to be authorised as a Product Reviewer for software under EU MDR and UK MDR, and who can work independently using Scarlet's assessment workflows.
Assess manufacturers' software lifecycle processes and technical documentation for medical device software (including 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 technical assessment findings with manufacturers, explaining requirements clearly and constructively.
Deliver consistent, high-quality assessments that match Scarlet's methodology and values.
Qualification
Working knowledge of IEC 62304Evidence of delivering consistentWillingness to adopt Scarlet's valuesPractical experience with generative AIInterview processOffer & references
Required
Bachelor's degree or higher in software engineering, computer science, electrical/electronic engineering or a closely related field.
Minimum 4 years of professional experience in the medical device industry or another safety-critical sector, including a minimum of 2 years designing, developing or testing safety-critical software.
Prior work as a Product Reviewer (technical documentation assessor) for a notified body or UK approved body, covering software devices (e.g. MDA 0315 / MDS 1011).
Working knowledge of IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1 and medical device cybersecurity (e.g. IEC 81001-5-1, MDCG 2019-16).
Practical experience with software development fundamentals: lifecycle processes, verification and validation testing, configuration management and cybersecurity.
Evidence of confidently interpreting and applying regulatory requirements to software technical documentation.
Evidence of delivering consistent, high-quality technical documentation assessments.
Experience assessing software as a medical device (SaMD).
Ability to explain findings and requirements clearly and constructively, in writing and verbally.
Ability to deliver assessments independently with minimal oversight.
Willingness to adopt Scarlet's values, assessment methods and tooling.
Preferred
Experience assessing AI/ML-enabled medical devices.
Practical experience with generative AI, such as LLMs, embeddings, RAG, fine-tuning and evaluation/monitoring.
Familiarity with relevant guidance such as MDCG 2019-11 (software qualification and classification) and MDCG 2020-1 (clinical evaluation of software).
Interview process
Introductory call with Guni (20 minutes)
Two product reviewer competence and regulatory interviews (30–45 minutes each)
