Scarlet, authorised to assess and certify medical devices, is hiring a Medical Device Auditor to audit medical device manufacturers’ quality management systems and produce clear conclusions that support certification decisions, combining clinical, technical, and regulatory expertise with AI agents and software.
About the Company — Scarlet’s Certification Model
Company Mission: Pulling medical technology from the future to solve human health
Authorization: Authorised to assess and certify medical devices
Approach: Combining clinical, technical, and regulatory expertise with AI agents and software
Customer Impact: Cut a year or more from certification timelines for new AI-enabled medical devices
Cycle Improvement: Shortened product-update cycles from months to weeks
Career Impact & Medical Device Auditing Opportunity
Technical Ownership: Plan and conduct QMS audits against ISO 13485, EU MDR, and UK MDR requirements
Limited Travel: Occasional trips required, but travel is generally limited
Training Provided: Receive training in Scarlet’s audit methods and tools
Career Growth: Help build infrastructure making faster, rigorous certification repeatable at scale
Position Overview
As a Medical Device Auditor at Scarlet, you will audit medical device manufacturers’ quality management systems and produce clear conclusions that support certification decisions. Your work will combine reviewing evidence with conversations about how manufacturers’ processes work in practice, helping safe devices reach patients sooner.
Why This Role Matters: As Medical Device Auditor, you 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 regulatory 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, and contribute to building the infrastructure that helps cut certification timelines by a year or more for AI-enabled medical devices, helping safe devices reach patients sooner.
Key Responsibilities
QMS Audit Planning & Execution
- Plan and conduct QMS audits against ISO 13485, EU MDR, and UK MDR requirements
- Review records and interview teams to assess whether processes meet requirements
Documentation & Reporting
- Document evidence, findings, and conclusions in clear, timely audit reports
Customer Communication
- Explain findings constructively and keep customers informed throughout the audit
Corrective Action Review
- Review corrective actions and the evidence needed to close findings
Qualifications & Requirements
Educational Requirements
- A degree in a relevant scientific, engineering, or medical discipline
Experience Requirements
- 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
Essential Skills
- Experience explaining audit findings or regulatory requirements clearly, in writing and conversation
- Experience with software demonstrating knowledge of software design, validation, testing, and debugging
Preferred Qualifications
- Experience conducting audits for a certification or notified body
- Experience with medical device software
About Scarlet
Scarlet is authorised to assess and certify medical devices, combining 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. Scarlet’s 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.
Career Excellence: Join a team building the infrastructure that makes faster, rigorous medical device certification repeatable at scale, helping safe devices reach patients sooner.
Who Should Apply?
- ISO 13485 QMS Auditors: With 2+ years auditing or managing quality management systems
- Medical Device Industry Professionals: With 4+ years of relevant sector experience
- EU/UK MDR Specialists: Familiar with European and UK medical device regulations
- Notified Body Auditors: With prior certification body audit experience
- Medical Device Software Reviewers: Comfortable assessing software design and validation
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