Regulatory Affairs Specialist
vor 4 Stunden
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 Associate
vor 3 Wochen
City of Brisbane, Österreich DTS Regulatory Consultants VollzeitA leading regulatory consultancy firm based in Brisbane is seeking an Associate Scientific Regulatory Consultant to support regulatory affairs related to agricultural products. The ideal candidate will have a degree in a scientific discipline and at least 3 years of relevant experience. This is a full-time position with a four-day work week, located in...
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Regulatory Affairs Specialist
vor 2 Wochen
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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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. This is a unique 12‑month contract opportunity to drive high‑impact APAC...
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Regulatory Affairs Senior Specialist
vor 3 Wochen
City of Melbourne, Österreich at VollzeitAdd expected salary to your profile for insights Position Title: Regulatory Affairs Senior Specialist Reports To: Quality and Regulatory Lead Location(s): Australia Purpose of the Function The Regulatory Affairs Senior Specialist is responsible for maintaining a portfolio of products, preparing regulatory applications for submission, promoting regulatory...
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Regulatory Affairs Senior Specialist
vor 3 Wochen
City of Melbourne, Österreich Bridgewest Perth Pharma VollzeitPosition Title Regulatory Affairs Senior Specialist Reports To Quality and Regulatory Lead Location(s) Australia Purpose of the Function The Regulatory Affairs Senior Specialist is responsible for maintaining a portfolio of products, preparing regulatory applications for submission, promoting regulatory compliance through active participation in the...
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Regulatory Affairs Specialist
vor 4 Wochen
City of Melbourne, Österreich black.ai VollzeitLocation Melbourne HQ or Sydney Employment Type Full time Department Compliance About Heidi Heidi is on a mission to halve the time it takes to deliver world-class care. We believe that by 2050, every clinician will practice with AI systems that free them from administrative burdens and increase the quality and accessibility of care to patients across the...
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City of Melbourne, Österreich at VollzeitA leading biotech firm in Australia is looking for an experienced Regulatory Affairs Senior Specialist to oversee product portfolios and ensure compliance with regulatory requirements. The ideal candidate will have a strong background in Pharmaceutical Regulatory Affairs with at least 5 years of experience, embedded in a dynamic team environment. This role...
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APAC Regulatory Affairs Specialist
vor 5 Stunden
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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Senior Regulatory Affairs Specialist
vor 2 Wochen
Council of the City of Sydney, Österreich ICON VollzeitSenior Regulatory Affairs Specialist-Office Base-South Korea ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Regulatory...
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Regulatory Affairs Associates
vor 4 Wochen
City of Brisbane, Österreich Scendea VollzeitDirect message the job poster from Scendea Are you looking to start or advance your career in regulatory affairs? At Scendea, we deliver market-leading scientific expertise and regulatory solutions to advance healthcare innovation worldwide. We are dedicated to streamlining medicinal product development, reducing time-to-market, and minimising costs for our...
