Medical Device Auditor
Scarlet
Medical Device Auditor
Scarlet
Certification framework for software medical devices
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.
As a Medical Device Auditor at Scarlet based out of either our London or Sweden office, you will audit medical device manufacturers’ quality management systems and produce clear conclusions that support certification decisions. You’ll receive training in Scarlet’s audit methods and tools. Your work will combine reviewing evidence with conversations about how manufacturers’ processes work in practice. Travel will be limited, though occasional trips may be required. You will help safe devices reach patients sooner.
Plan and conduct QMS audits against ISO 13485, EU MDR and UK MDR requirements.
Review records and interview teams to assess whether their processes meet the requirements.
Document evidence, findings and conclusions in clear, timely audit reports.
Explain findings constructively and keep customers informed throughout the audit.
Review corrective actions and the evidence needed to close findings.
A degree in a relevant scientific, engineering or medical discipline.
At least four years’ experience in the medical device industry, including two years auditing or managing an ISO 13485 QMS.
Working knowledge of EU MDR or UK MDR requirements for quality management systems.
Experience explaining audit findings or regulatory requirements clearly, in writing and in conversation.
Experience with software demonstrating knowledge of software design, validation, testing, debugging and interactions with its operating environment.
Experience conducting audits for a certification or notified body.
Experience with medical device software.
Scarlet provides a platform-based service for certifying Software Medical Devices. It targets manufacturers of medical software and regulatory bodies, offering a framework that enables scalable, continuous development and monitoring of software products to meet regulatory requirements. The platform streamlines the certification process by allowing both manufacturers and regulators to build, certify, and oversee software in a coordinated, ongoing cycle rather than a one-time check. Scarlet differentiates itself by addressing gaps in the current regulatory approach to fast-evolving health software, emphasizing scalable, continuous monitoring and collaboration between sponsors and regulators. Its goal is to get safe, life-saving medical software to patients faster while helping make healthcare more accessible and affordable for people everywhere.
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