Quality Manager, Medical Technology

Quality Manager, Medical Technology

TELIX PHARMACEUTICALS LIMITED

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation.  At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases.  You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.   The role is an EU-based Quality Manager position to support and maintain Medical Device Quality Management System (QMS) in operation, and to expand the existing QMS in order to incorporate incoming AI development platform(s), clinical decision support systems (CDSS) as Software as a Medical Device (SaMD) applications, as well as future incoming medical device(s). The Quality Manager ensures that the QMS is able to support the design, development, and commercialization of future products ensuring regulatory and quality requirements are met to achieve appropriate global approvals in line with regulations and standards such as but not limited to EU MDR, ISO 13485, 21CFR820, ISO14971, IEC 62304; the... Rwanda : Eastern Province Kigali Province Northern Province Southern Province Western Province International [Click the Apply button below to see the contact details]

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