Product Reviewer – Contractor

Scarlet; United States; À distance; USD 83 000 - 165 000; Plein temps

Résumé du poste

Scarlet seeks a remote Product Reviewer (Contractor) to independently assess medical device software documentation under EU MDR/UK MDR and IEC standards. You will review lifecycle processes and technical docs for SaMD and AI-enabled devices, raising findings and guiding manufacturers to meet requirements with Scarlet's proven approach.

The role offers flexible scheduling, requires 4+ years in safety-critical software and prior reviewer experience, and emphasizes clear written and verbal

Qualifications

• Bachelor's degree or higher in software/engineering field.
• 4+ years in medical device industry or safety-critical sector.
• 2+ years designing, developing or testing safety-critical software.
• Experience as Product Reviewer for a notified body or UK approved body (software devices).
• Knowledge of IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, IEC 81001-5-1.

Responsabilités

• Assess software life cycle processes and technical documentation for medical device software (SaMD/AI-enabled).
• Raise and close out technical assessment findings with manufacturers, with clear requirements.
• Deliver consistent, high-quality assessments that align with Scarlet's methodology.

Connaissances

Regulatory compliance knowledge

Technical documentation assessment

Independent work

Communication skills

Formation

Bachelor's degree or higher in software/engineering field

Outils

IEC 62304

ISO 14971

IEC 82304-1

Description du poste

We pull medical technology from the future to solve human health.

Scarlet is authorised to assess and certify medical devices. We combine clinical, technical and regulatory expertise with AI agents and software so rigorous certification can keep pace with product development at the world’s most ambitious technology companies, without lowering the safety bar.

Our customers have cut a year or more from their certification timelines for new AI-enabled medical devices and shortened product-update cycles from months to weeks. You’ll join a team building the infrastructure that makes these outcomes repeatable at scale.

About the role

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.

The role is fully remote, with flexible scheduling, subject to assessment demand and availability.

Responsibilities

• - 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.

Required qualifications

• - 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 qualifications

• - 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

1. 1. Introductory call with Guni (20 minutes)
2. 2. Two product reviewer competence and regulatory interviews (30-45 minutes each)
3. 3. Offer & references