Product Reviewer – Contractor

About this role

Independently assess technical documentation and software lifecycle processes for medical device software, including SaMD and AI-enabled devices. The contractor role is fully remote with flexible scheduling, subject to assessment demand and availability.

About the company

Scarlet is a notified body that certifies AI and software medical devices under EU MDR and UK MDR without unnecessary delays.

The team

Devices and Software

Stack

What you'll do

• Assess software lifecycle processes and medical device software technical documentation against applicable regulations and standards.
• Raise and close technical assessment findings with manufacturers, explaining requirements clearly and constructively.
• Deliver consistent, high-quality assessments using Scarlet's methodology.

What we're looking for

• Bachelor's degree or higher in software engineering, computer science, electrical/electronic engineering, or a related field.
• At least 4 years of experience in medical devices or another safety-critical sector, including 2 years designing, developing, or testing safety-critical software.
• Prior notified body or UK approved body experience as a Product Reviewer for software devices.
• Experience assessing SaMD and applying regulatory requirements to software technical documentation.
• Working knowledge of relevant software lifecycle, risk management, usability, and cybersecurity standards.
• Able to deliver assessments independently and communicate findings clearly.

Nice to have

• Experience assessing AI/ML-enabled medical devices.
• Practical experience with generative AI, including LLMs, embeddings, RAG, fine-tuning, or evaluation and monitoring.
• Familiarity with MDCG 2019-11 and MDCG 2020-1.

Hiring process

1. 20-minute introductory call
2. Two product reviewer competence and regulatory interviews, each 30–45 minutes
3. Offer and references