Product Reviewer – Contractor

This is a fully remote position, open to applicants in United States.

📋 Description

• Efficiently deliver high-quality technical documentation assessments for medical device software independently.

• Evaluate manufacturers' software lifecycle processes and technical documentation for medical device software, including Software as a Medical Device (SaMD) and AI-enabled devices, in compliance with EU MDR, UK MDR, IEC 62304, IEC 82304-1, IEC 62366-1, and IEC 81001-5-1.

• Identify and resolve technical assessment findings with manufacturers.

• Clearly and constructively articulate requirements.

• Provide consistent, high-quality assessments that align with Scarlet's methodology and core values.

• Operate independently within Scarlet's assessment workflows.

⛳️ Requirements

• A Bachelor's degree or higher in software engineering, computer science, electrical/electronic engineering, or a closely related discipline.

• At least 4 years of professional experience in the medical device industry or another safety-critical sector.

• A minimum of 2 years in designing, developing, or testing safety-critical software.

• Previous experience as a Product Reviewer (technical documentation assessor) for a notified body or UK approved body, focusing on software devices (e.g., MDA 0315 / MDS 1011).

• Familiarity with IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, and medical device cybersecurity (e.g., IEC 81001-5-1, MDCG 2019-16).

• Hands-on experience with software development fundamentals, including lifecycle processes, verification and validation testing, configuration management, and cybersecurity.

• Proven ability to confidently interpret and apply regulatory requirements to software technical documentation.

• Demonstrated experience in delivering consistent, high-quality technical documentation assessments.

• Experience in assessing Software as a Medical Device (SaMD).

• Capability to clearly and constructively explain findings and requirements, both in writing and verbally.

• Ability to conduct assessments independently with minimal supervision.

• Commitment to adopting Scarlet's values, assessment methods, and tools.

• Experience in assessing AI/ML-enabled medical devices is preferred.

• Practical knowledge of generative AI, including LLMs, embeddings, RAG, fine-tuning, and evaluation/monitoring is preferred.

• Familiarity with MDCG 2019-11 and MDCG 2020-1 is preferred.

🏝️ Benefits

• Fully remote work.

• Flexible scheduling, depending on assessment demand and availability.