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 roleAs a Quality Auditor at Scarlet, 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.
ResponsibilitiesPlan 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.
Introductory call with Sandy — 30 minutes.
QMS audit exercise and discussion with Felicia — 60 minutes.
Culture and values interviews with James and Jamie — 30 minutes each.
References and offer.
Skills Required
- Degree in a relevant scientific, engineering, or medical discipline
- At least four years of experience in the medical device industry
- At least two years auditing or managing an ISO 13485 quality management system
- Working knowledge of EU MDR or UK MDR quality management system requirements
- Experience clearly explaining audit findings or regulatory requirements in writing and conversation
- Experience with 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
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What We Do
Scarlet certifies software medical devices. We are Europe’s only Notified Body specialised in Software & AI. Our mission is to hasten the transition to accessible, affordable healthcare. We strive to achieve our mission by enabling our customers to deliver on theirs, and get their life-changing technology to the people who need it. Scarlet was built specifically for software and AI medical devices. We help customers to get their SaMD certified in the EU & UK, and ship the kind of regular updates inherent to good software, ensuring patients can safely get the most up-to-date technology. Scarlet is designated as an EU Notified Body under regulation (EU) 2017/745 (EU MDR). And a UK Approved Body under UK Medical Devices Regulations 2002 (SI 2002/618 as amended). Scarlet is also accredited to issue ISO 13485 certificates
