Quality Assurance and Regulatory Affairs Manager
We are currently seeking an experienced and passionate QARA Manager to join our Pacific organization. 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. This position will be reporting into our Regional Head QA and RA-Asia Pacific.
Location
Noble Park-Melbourne
Your responsibilities
* Overall responsibility for the company's quality management system and its ongoing evolution and development.
* Continuous improvement of current processes and systems relating to regulatory affairs and compliance e.g., ISO13485, TGA, Med safe.
* Lead internal and external quality audits.
* Ensure the 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.
* 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
* 5+ years' experience in Quality Assurance and Regulatory Affairs within the medical device industry, ideally with team management experience.
* Hands‑on regulatory submissions experience with TGA.
* Dental industry experience will be highly regarded.
* Project Management or Lean methodology experience is an advantage.
Join us on our journey to shape the future of dentistry
Ivoclar Vivadent is one of the world's leading dental companies with approximately 3600 employees. We love innovation and we thrive on it. We are known for our long‑standing experience and high quality. 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
In order to achieve this goal, we are looking for people with good ideas, courage and exceptional drive: Focused minds who share our passion. We offer a multifaceted work environment which is characterized by mutual respect and close collaboration. We translate words into action and continue to evolve. Become part of our team today.
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.
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