Product Reviewer – Contractor
Scarlet
WorldwideFully remoteContractSeniorHealthcare & Telemedicine
Posted 3 hours ago3h agoApply link checked 2 hours ago
Why we think you can apply
- Hiring model
- Open worldwide · the employer states no country restriction
- Work from
- Anywhere, the UAE included
Posted 3 hours ago · apply link checked 2 hours ago
About the role
Responsibilities
- Assess manufacturers' software lifecycle processes and technical documentation for medical device software
- Raise and close out technical assessment findings with manufacturers
- Deliver consistent, high-quality assessments matching Scarlet's methodology
Requirements
- Bachelor's degree in software engineering, computer science, or related field
- 4+ years in medical device or safety-critical sector, including 2+ years on safety-critical software
- Prior notified body or UK approved body product reviewer experience for software devices
- Working knowledge of IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, IEC 81001-5-1
- Ability to assess software as a medical device (SaMD) independently
Preferred Qualifications
- Experience assessing AI/ML-enabled medical devices
- Practical generative AI experience
- Familiarity with MDCG 2019-11 and MDCG 2020-1
About the Company
Scarlet is authorised to assess and certify medical devices, combining clinical, technical and regulatory expertise with AI agents and software.
What we look for
- Bachelor's degree in software engineering, computer science, or related field
- 4+ years in medical device or safety-critical sector, including 2+ years on safety-critical software
- Prior notified body or UK approved body product reviewer experience for software devices
- Working knowledge of IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, IEC 81001-5-1
- Ability to assess software as a medical device (SaMD) independently
- Experience assessing AI/ML-enabled medical devices
- Practical generative AI experience
- Familiarity with MDCG 2019-11 and MDCG 2020-1
CybersecurityComplianceAIRegulatoryQuality AssurancesafetyMedicineMedical Devices
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Scarlet
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