Job
Core
Lead regulatory compliance and quality assurance for AI-powered cardiovascular disease detection tools, ensuring adherence to international medical device standards.
Role type
Quality Manager (Medical Device Regulatory)
Builds
FDA 510(k), CE (MDR 2017/745), and ISO 13485 certified medical technology products
Domain
Healthcare technology / Medical devices / AI
Deliverable
client delivery
Required skills
FDA 510(k) certification, CE MDR 2017/745 compliance, ISO 13485 QMS management, risk assessment, internal auditing, regulatory documentation, strategic reporting
Preferred skills
IEC 62304, ISO 14971, medical software cybersecurity standards, AI medical software validation
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