PrecisionLife is seeking a Senior RA/QA leader to drive regulatory strategy and quality systems for its Mechanostic products. The role requires building and maintaining QMS to ISO 13485 and applicable FDA/UKIVDR standards, overseeing audits, and guiding audits with Notified Bodies.
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You will manage risk, lifecycle compliance, and regulatory submissions in collaboration with R&D;, clinical and commercial teams.
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📌 Senior VP, Regulatory Affairs & QA for AI/SaMD (Seven Mile Beach)
🏢 ONE NUCLEUS
📍 Seven Mile Beach
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