Lead Auditor - Contractor role jobs in United States
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Scarlet · 2 days ago

Lead Auditor - Contractor role

positionUnited States
timeFull-time, Contract
remoteRemote
seniorityMid, Senior Level
date4+ years exp

Scarlet is a leading authority on AI medical devices, focused on making healthcare universally accessible. The role involves conducting audits of medical device manufacturers’ Quality Management Systems to ensure compliance with regulatory standards such as ISO 13485, EU MDR, and UK MDR.

MedicalSoftwareTest and Measurement

Responsibilities

Conduct remote audits of medical device manufacturers’ Quality Management Systems under ISO 13485, EU MDR, and UK MDR
Provide clear, structured audit documentation and evidence-based conclusions
Contribute to consistent, high-quality audit experiences aligned with Scarlet’s audit methodology and values

Qualification

ISO 13485EU MDRUK MDRLead Auditor experienceMedical device industrySoftware medical devicesClear communicatorQuality focusRegulatory judgementIndependent & reliable

Required

Bachelor's degree in software engineering
Bachelor's degree in computer science
Bachelor's degree in physics or biophysics
Bachelor's degree in biology or microbiology
Bachelor's degree in chemistry or biochemistry
Bachelor's degree in electrical, electronic, mechanical engineering or bioengineering
Bachelor's degree in human physiology
Bachelor's degree in medicine
Bachelor's degree in pharmacy
Minimum 4 years of experience in the medical device industry
Minimum 2 years of experience auditing or managing QMSs under ISO 13485
Minimum 2 years of experience auditing or managing QMSs under EU MDR and/or UK MDR
Prior work with notified bodies or accreditation bodies as a Lead Auditor
Experience with software medical devices (SaMD) is strongly preferred
Working knowledge of relevant standards, such as ISO 14971
Working knowledge of relevant standards, such as IEC 62304
Working knowledge of relevant standards, such as IEC 82304
Working knowledge of relevant standards, such as Cybersecurity

Preferred

Practical experience working with software

Company

Scarlet

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Europe’s only Notified Body specialised in software and AI.
dateFounded in 2020
location
London, England, GBR
people-size51-200 employees
web-link
https://www.scarlet.cc/

Funding

Current Stage
Growth Stage
Total Funding
$26.55M
Key Investors
AtomicoCreandum
2024-06-14Series A· $17.5M
2022-08-30Seed· $7M
2021-01-29Pre Seed· $2.06M

Leadership Team

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James Cox
Co-Founder
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J
James Dewar
Co-Founder
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Recent News

EIN Presswire
Scarlet by Masoud Najafi Amirkiasar Wins Silver in A' Packaging Design Awards
2025-12-09
Company data provided by crunchbase