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Scarlet

Scarlet - Lead Auditor - Contractor role

Remote - United States, European Union3mo ago
RemoteStaffNAMedical DevicesDigital HealthGovernmentAuditorDocumentation

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Requirements

• Bachelor’s degree in: • software engineering • computer science • physics or biophysics • biology or microbiology • chemistry or biochemistry • electrical, electronic, mechanical engineering or bioengineering • human physiology • Minimum 4 years of experience in the medical device industry • Minimum 2 years of experience auditing or managing QMSs under: • EU MDR and/or UK MDR • Preferred: Practical experience working with software. • 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: • Strong regulatory judgement — you are confident in interpreting and applying regulatory requirements. • Consistency & quality focus — you care deeply about audit quality and repeatability. • Clear communicator — you explain findings and requirements clearly and constructively. • Independent & reliable — you can deliver audits with minimal oversight • Aligned mindset — you are open to adopting Scarlet’s values, audit methods and tooling. • Engagement model • Consultant auditor role • Flexible scheduling, subject to audit demand and availability

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.

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