Quality Assurance and Regulatory Affairs Manager

vor 4 Wochen

City of Melbourne, Österreich Ivoclar NA Vollzeit

Quality Assurance and Regulatory Affairs Manager We are currently seeking an experienced and passionate QA/RA Manager to join our team on a 12-month contract. This position is based in our offices in Noble Park, Melbourne and responsible for Quality Assurance and Regulatory Affairs for both Australia and New Zealand. Location Noble Park, Melbourne, Victoria, Australia Your Responsibilities Overall responsibility for the company's quality management system and its ongoing evolution and development. Continuous improvement of current processes and systems related to regulatory affairs and compliance (e.g., ISO13485, TGA, Medsafe). Lead internal and external quality audits. Ensure investigation, assessment and decision‑making on any deviations, non‑conformances, corrective actions and change control. Lead, coach and mentor two direct reports to develop and grow their skills and knowledge. Manage and/or execute product registration processes for the Pacific region. Coordinate regulatory activities and associated tasks with suppliers and other company subsidiaries as required. Support and promote occupational health & safety policies and initiatives. About You 3+ years' experience in Quality Assurance and Regulatory Affairs within the medical device industry. Dental experience will be looked upon favourably. Project Management experience. Excellent communication and problem‑solving skills. Previous people management experience preferred. Intermediate to advanced computer skills including MS Office. About the Company Ivoclar Vivadent is one of the world's leading dental companies with approximately 3500 employees. We love innovation and thrive on it. We are guided by our strong values and the company culture of a sustainably operated family‑owned business with a long‑term vision. Our mission is making people smile. How to Apply If you believe you have the necessary skills for this position, we would like to hear from you by sending your resume and covering letter addressing the key selection criteria listed above. #J-18808-Ljbffr

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    vor 3 Wochen

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