Regulatory Affairs Specialist
Vor 6 Tagen
Regulatory Affairs Specialist | 12-Month Contract Global Medical Devices Leader | APAC Focus | Sydney Step into a pivotal Regulatory Affairs role with a global, award‑winning medical devices company whose technologies are used by healthcare professionals in over 160 countries. This is a unique 12‑month contract opportunity to drive high‑impact APAC registration activities while working with a seasoned regional RA team based in Sydney. The Opportunity As Regulatory Affairs Specialist – you will be part of the APAC Regulatory Affairs team supporting a broad portfolio of infectious disease and related medical device products. You will take ownership of key regulatory activities across change control, and regional submissions, working closely with global RA, manufacturing sites, supply chain, commercial and distributor partners Responsibilities Manage all aspects of product registrations across Australia and New Zealand, ensuring timely approvals in line with business objectives. Liaise with regulatory authorities including the TGA and Medsafe to support evaluation and approval processes. Prepare and coordinate regulatory submissions and responses to requests for further information. Review and ensure compliance of product labelling, instructions for use, and promotional materials with applicable regulations and codes. Analyse scientific data in registration packages to ensure readiness and compliance prior to submission. Support regulatory compliance activities including product recalls, safety alerts, and end-of-life notifications. Maintain up-to-date knowledge of relevant regulatory standards, guidelines, and procedures (e.g., ISO, TGA regulations). Contribute to quality, safety, and environmental compliance by adhering to internal policies and external requirements. Skills Tertiary qualification in Science or a related discipline 4–5 years’ experience in Regulatory Affairs and/or Quality within the medical device industry. Strong working knowledge of Australian regulatory requirements, including TGA and Medsafe processes. Demonstrated ability to work independently and manage regulatory tasks with minimal supervision. Confident in navigating and interpreting regulatory guidelines and standards (e.g., ISO 13485, QMS). Able to hit the ground running in a fast‑paced environment, particularly within a short‑term contract setting. Apply directly here, or send your updated CV to Keeley Munday at #J-18808-Ljbffr
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Regulatory Affairs Specialist
vor 1 Woche
Council of the City of Sydney, Österreich i-Pharm Consulting VollzeitRegulatory Affairs Specialist – 12‑Month Contract Global Medical Devices Leader | APAC Focus | Sydney Step into a pivotal Regulatory Affairs role with a global, award‑winning medical devices company whose technologies are used by healthcare professionals in over 160 countries. The Opportunity As Regulatory Affairs Specialist – you will be part of the...
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