Product Reviewer – Contractor

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

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👻 Ghost score 25%

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Scarlet

WebsiteLinkedInAll Job Openings

1 - 10 employees

📚 Education

👥 HR Tech

⚡ Productivity

Education • HR Tech • Productivity

Scarlet is a company dedicated to leadership development across various stages of life. It offers customized courses and tips for both in-person and virtual formats to help leaders elevate their skills and make a real impact. Scarlet provides training in areas such as intern etiquette, business networking, presentation skills, and socializing effectively in business environments. The company emphasizes personal growth, authentic communication, and unlocking leadership potential. Scarlet aims to support individuals in navigating life and leadership with confidence and skill.

📋 Description

• Independently deliver efficient, high-quality technical documentation assessments of medical device software • 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 • Explain requirements clearly and constructively • Deliver consistent, high-quality assessments aligned with Scarlet's methodology and values • Work independently using Scarlet's assessment workflows

🎯 Requirements

• 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 • Minimum 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 • Experience assessing AI/ML-enabled medical devices (preferred) • Practical experience with generative AI, such as LLMs, embeddings, RAG, fine-tuning and evaluation/monitoring (preferred) • Familiarity with MDCG 2019-11 and MDCG 2020-1 (preferred)

🏖️ Benefits

• Fully remote work • Flexible scheduling, subject to assessment demand and availability

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