Lead Auditor - Contractor role

Scarlet(26 days ago)

RemoteFull TimeSenior$103,034 - $140,181 (estimated)Quality

About this role

The Lead Auditor at Scarlet is responsible for conducting remote audits of medical device manufacturers' Quality Management Systems in compliance with ISO 13485, EU MDR, and UK MDR standards. This part-time contractor role requires the auditor to provide structured documentation and evidence-based conclusions while ensuring a consistent and high-quality audit experience aligned with Scarlet's methodologies. Candidates must have a relevant educational background, substantial medical device industry experience, and prior auditing work with notified bodies.

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Required Skills

ISO 13485
EU MDR
UK MDR
Auditing
Quality Management Systems
Regulatory Standards
Documentation
Communication Skills
Independent Work
Attention to Detail

+5 more

Qualifications

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 engineering
Bachelor’s degree in electronic engineering
Bachelor’s degree in mechanical engineering
Bachelor’s degree in bioengineering
Bachelor’s degree in human physiology

+7 more

About Scarlet

www.scarlet.cc

Scarlet is Europe's only Notified Body specializing in the certification of software and AI as medical devices. The company streamlines the certification process for Software as a Medical Device (SaMD) and AI-based Medical Devices (AIaMD), helping manufacturers bring their innovative solutions to market efficiently. Scarlet's mission is to facilitate the transition to universally accessible healthcare by enabling their clients to meet regulatory standards without unnecessary delays. By focusing on specialized processes for software and AI technology, Scarlet aims to enhance the overall quality and availability of healthcare solutions.