Head of Quality

vor 3 Wochen


City of Melbourne, Österreich SDI Limited Vollzeit

We are a Global Business leading the market with Australian made and owned dental restorative products, teeth whitening and small equipment. Founded in 1972, SDI products are now distributed in over 100 countries throughout the world. Our global head office and manufacturing plant is located in Melbourne with overseas branch offices and warehousing in the USA, Brazil and Germany. The Head of Quality is responsible for: Leading effective management of departmental activities to achieve company strategic goals and adhere to company policies. Providing the leadership and management necessary to ensure that SDI is QMS, legal and product regulations compliant. Monitoring and maintaining local and overseas compliance with regulatory affairs requirements. Conducting work in a safe manner and demonstrating a strong commitment to SDI's values of passion, accountability, respect, teamwork and innovation. Leads and manages the product compliance and registration process for local and international regions Assumes the role of Management Representative for regulatory bodies such as TGA, EU, FDA, Health Canada, Brazil, Japan, South America, Asia, Middle East etc. Ensures processes needed for the QMS are effectively documented to meet compliance requirements Ensures awareness of applicable regulatory requirements and QMS requirements throughout SDI Leads and manages SDI's QMS to ensure compliance with various regulations such as ISO13485, MDSAP, GMP etc. Manages and leads SDI's product registration program in a timely manner as required Manages and maintains systems to ensure SDI is up to date with changes and the ongoing development of QMS's and regulatory requirements Monitors and reviews activities of regulatory bodies such as, but not limited to, TGA, MDR, FDA, Health Canada, Brazil, South America, Asia, Middle East, REACH, WEEE, etc. Prepares a regular Regulatory Affairs report which identifies and reviews progress on product registrations and renewals for all key SDI regions Liaises with SDI offices overseas and distributors on registration requirements and submissions Monitors and maintains SDI's trademarks and IP related to SDI products #J-18808-Ljbffr


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