At a Glance
- Tasks: Audit and certify quality management systems for innovative AI healthtech devices.
- Company: Scarlet, a forward-thinking company in the heart of London.
- Benefits: Equity options, competitive salary, and opportunities for professional growth.
- Other info: Join a dynamic team focused on rapid yet safe market access.
- Why this job: Shape the future of healthcare with cutting-edge technology and standards.
- Qualifications: 4+ years in medical devices and strong regulatory auditing experience required.
The predicted salary is between 50000 - 70000 £ per year.
Scarlet in London is seeking a Medical Device Quality Engineer to audit and certify QMS for AI-driven medical devices and software.
You will interpret ISO 13485, EU MDR, and emerging standards like ISO 42001, shaping software-first audit processes for rapid but safe market access.
Ideal candidates have 4+ years in medical devices, including 2+ years on ISO 13485, with strong regulatory auditing experience for EU MDR and IEC 62304.
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We think you need these skills to ace Medical Device QMS Auditor for AI Healthtech – Equity
ISO 13485
EU MDR
ISO 42001
IEC 62304
Regulatory Auditing
Quality Management Systems (QMS)
Medical Device Standards
