Regulatory Affairs Specialist
vor 4 Wochen
Regulatory Affairs Specialist | 12-Month Contract Global Medical Devices Leader | APAC Focus | Brisbane 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 Brisbane. 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 *******@i-pharmconsulting.com . #J-18808-Ljbffr
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Regulatory Affairs Specialist
vor 3 Wochen
City of Brisbane, Österreich i-Pharm Consulting VollzeitBase pay range A$80.00/hr - A$90.00/hr Regulatory Affairs Specialist | 12-Month Contract Global Medical Devices Leader | APAC Focus | Brisbane 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...
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City of Brisbane, Österreich i-Pharm Consulting VollzeitA global medical devices leader in Brisbane is looking for a Regulatory Affairs Specialist for a 12-month contract. You will manage product registrations across Australia and New Zealand, liaising with regulatory authorities like the TGA and Medsafe. Ideal candidates will have at least 4 years of experience in Regulatory Affairs in the medical device...
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APAC Regulatory Affairs Specialist
vor 4 Wochen
City of Brisbane, Österreich i-Pharm Consulting VollzeitA global medical devices leader located in Brisbane is seeking a Regulatory Affairs Specialist for a unique 12-month contract. In this role, you will manage product registrations across Australia and New Zealand while collaborating with regulatory authorities. Candidates should possess a tertiary qualification in Science and have 4–5 years of relevant...
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Regulatory Affairs Associate
vor 4 Wochen
Council of the City of Sydney, Österreich EPHealthcare VollzeitRegulatory Affairs Associate – Fixed-Term Contract (until June 2026) A fixed‑term role (until June 2026) with the potential to become permanent. Reporting to the Regulatory Affairs Manager, you will ensure ongoing compliance with TGA requirements, support product registrations, and manage lifecycle activities across an innovative portfolio. Why you’ll...
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Regulatory Affairs Specialist
vor 3 Wochen
Council of the City of Sydney, Österreich EPHealthcare VollzeitA leading pharmaceutical company in Australia is seeking a detail-oriented Regulatory Affairs Associate for a fixed-term contract until June 2026. The role involves ensuring compliance with regulatory requirements, preparing documentation for product registrations, and liaising with cross-functional teams. The ideal candidate will have a B.Sc. or relevant...
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Regulatory & Technical Affairs Specialist
Vor 7 Tagen
Council of the City of Sydney, Österreich Caruso's Natural Health VollzeitA leading Australian health company is seeking a Regulatory and Technical Affairs Associate to ensure compliance with regulatory standards for their product range. The ideal candidate will have over 3 years of experience in a similar role, along with a relevant degree. Strong regulatory knowledge and critical analysis skills are required. This full-time...
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Part-Time Quality
vor 4 Wochen
City of Melbourne, Österreich Austramedex VollzeitA medical device manufacturing firm in Melbourne is seeking a part-time Quality and Regulatory Affairs Specialist to ensure compliance with Australian regulations and manage quality standards across operations. The ideal candidate has extensive experience with ISO 13485 systems and regulatory affairs. This role offers flexible hours and the opportunity to...
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Regulatory Affairs Business Partner
vor 4 Wochen
Council of the City of Ryde, Österreich Becton Dickinson VollzeitJob Description Summary Ready to take the next step in your career and move into Regulatory Affairs? Join a global leader in medical technology and play a key role in ensuring compliance while enabling business growth across Australia and New Zealand. Job Description At BD, possibility isn’t an idea. It’s what we do. We are the Makers of Possible. This...
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Senior Regulatory Affairs Associate
vor 3 Wochen
City of Melbourne, Österreich GSK VollzeitSenior Regulatory Affairs Associate (Contract) Company: GSK – Australia, Victoria – Abbotsford GSK is looking for a Senior Regulatory Affairs Associate to join a maternity leave contract until the end of January 2027. About the role As the Senior Regulatory Affairs Associate, you will help lead regulatory lifecycle activities that keep products licensed,...
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Regulatory Affairs Business Partner
vor 4 Wochen
Council of the City of Sydney, Österreich Becton Dickinson VollzeitJob Description Ready to take the next step in your career and move into Regulatory Affairs? Join a global leader in medical technology and play a key role in ensuring compliance while enabling business growth across Australia and New Zealand. Your Day-to-Day As a Regulatory Affairs Business Partner at BD, you’ll work closely with commercial and functional...
