Genea Biomedx Pty seeks a strategic, hands-on Quality Assurance & Regulatory Affairs Director to lead the QA/RA function for medical devices. Reporting to the COO, you will shape global regulatory strategy, ensure EN ISO 13485 compliance, and oversee audits by Notified Bodies, Competent Authorities, and the FDA.
You will develop QA/RA processes, mentor staff, drive CAPA and change control, and collaborate with manufacturing to deliver protected, effective fertility technology.
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📌 Global QA & Regulatory Affairs Leader - Medical Devices (Sydney)
🏢 Genea Biomedx Pty
📍 Sydney
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