Senior Regulatory Affairs Specialist

Macquarie Park, NSW
Permanent
Full-time

1 month ago

JOB DESCRIPTION:About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:Career development with an international company where you can grow the career you dream of .Amazing health and wellness benefits and perks.A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.OverviewThis role is responsible for the primary responsibility of regulatory activities in Australia and New Zealand. Including managing the regulatory submissions and product updates, approving advertising materials and being responsible for regulatory and legislation changes.ResponsibilitiesManage all aspects of product registration with regulatory authorities in Australia and New Zealand to ensure regulatory approvals are achieved in accordance with Company objectives. Monitor progress of applications through the regulatory system.Be the main contact for TGA and Medsafe to facilitate evaluation and other regulatory processes.Provide assessment on product and manufacturing changes in relation to regulatory actions.Review and approving promotional material for compliance with relevant regulations and codes.Be the SME of all Australian and New Zeal and Therapeutic Goods regulations and providing guidance and strategy for Affiliate and Global stakeholdersProvide training and guidance on Regulatory topics to stakeholders where applicable.Maintain good working knowledge of relevant Federal and State Regulations and standard guidelines and procedures.You may be required to work outside of your ordinary hours of work to participate in essential training, team meetings, customer events or trade shows/conferences. These events may take place on an evening and/or weekend.Qualifications and ExperienceEssentialScience Degree or equivalentMinimum 7 years Regulatory experience within the medical devices or IVD industry.The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: Regulatory OperationsDIVISION: ADC Diabetes CareLOCATION: Australia
Macquarie Park : 299 Lane Cove RoadADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Yes, 10 % of the TimeMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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