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Head of Quality & Regulatory AI SaMD & Biomarkers
Job in
Cambridge, Middlesex County, Massachusetts, 02140, USA
Listed on 2026-07-29
Listing for:
Qureight Ltd
Full Time
position Listed on 2026-07-29
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Qureight Ltd is seeking a Head of Quality Assurance and Regulatory Affairs to lead regulatory strategy and quality systems across clinical imaging and AI-enabled services. You will drive submissions for SaMD/AIaMD, biomarker validations, and liaise with FDA, MHRA, and other authorities.
You will embed a risk-based, compliant culture across GCP, ISO standards, and QA processes. You will balance rigorous regulatory requirements with pragmatic, scalable operations, shaping Qureight’s future in
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