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Head of Quality & Regulatory AI-Powered SaMD
Job in
4040, Basel, Kanton Basel-Landschaft, Switzerland
Listed on 2026-07-23
Listing for:
Specto Medical AG
Full Time
position Listed on 2026-07-23
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Specto Medical AG in Basel is seeking a Regulatory Affairs & Quality lead to take ownership of our eQMS and compliance program. You will drive FDA/Notified Body activities, define EU AI Act strategy, and ensure ISO 13485, ISO 14971, IEC 62304 compliance across the product lifecycle.
You will partner with engineering, ML, and clinical teams to translate regulatory requirements into scalable R&D guidance, maintain audit readiness, and support product development for Specto's AI-enabled medical
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