Job Title

CompanyWe 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.ResponsibilitiesManage high level regulatory submissions and product registrations both local and overseas.Co-ordinating registration renewal of existing products and facilities as needed.Monitoring and maintaining local and overseas compliance with regulatory affairs requirements.Providing submission guidance to Regulatory Affairs Associate(s), regulatory policies, and procedures.Conducting work in a safe manner and demonstrating a strong commitment to SDI''s values of passion, accountability, respect, teamwork, and innovation.Prepares and submits registration documents in regions such as TGA, FDA, EU, and as needed.Utilizes knowledge and experience to identify and tackle problems within the regulatory areas.Provides gap analysis and risk assessments for change control and complaints activities.Reviews and approves artworks such as marketing literature, product labelling or user manuals to ensure regulatory compliance.Monitors changes to products (e.g., labelling, product codes, formulation) & submit variations to relevant regulatory bodies as required.Supports the maintenance of completed products Technical Files conformed to MDR requirements.Liaises with Export staff on overseas requests for regulatory documentation.Liaises with SDI offices overseas and distributors on registration requirements and progress of ongoing production registration submissions.Monitors overseas re-registration requirements. Ensures that the renewals are submitted well in advance of certificate expiry dates.Develops and updates departmental procedures aligned with document control standards, ensuring all documentation is current and compliant.Assists in any regulatory actions including recalls and adverse events reporting.If you are interested in joining the team and are looking for a temporary position, please click Apply now!Desired Skills and ExperienceCo-ordinating both local and overseas registration of new products and ensuring that support documents are established and up to date.Seniority LevelAssociateEmployment TypeTemporaryJob FunctionScienceIndustriesManufacturing #J-18808-Ljbffr