Regulatory Affairs Specialist
15 hours ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs function, you will play a crucial role in ensuring the seamless approval and registration of designated products with local health authorities.
Your primary responsibility will be to develop and implement optimised regulatory strategies to guarantee products remain registered and labels are optimised throughout their lifecycle.
Key aspects of this role include:
Preparing, submitting, and managing the approval process of designated regulatory applications.
Developing expertise in local operational processes and systems associated with product information, artwork, planned, and ongoing registration activities.
Collaborating with cross-functional stakeholders to ensure the entire product portfolio remains fully compliant with external and internal requirements.
Working with internal stakeholders to develop and optimise new and existing internal processes and systems.
Providing regulatory input into pre-market, post-market, and business activities as required.
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Regulatory Affairs Specialist
2 weeks ago
Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $120,000 - $205,000Job Title: Regulatory Affairs SpecialistOur organization seeks an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will possess a deep understanding of global regulations and standards, with a proven track record of developing and implementing effective regulatory strategies.About the Role:The Regulatory Affairs Specialist will...
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Regulatory Affairs Specialist
2 weeks ago
Sydney, New South Wales, Australia beBeeCompliance Full time $160,000 - $200,000Regulatory Affairs SpecialistStryker is a global leader in medical technologies, driven to make healthcare better. We offer innovative products and services that help improve patient and healthcare outcomes.About the RoleThe Regulatory Affairs Lead is responsible for overseeing key regulatory activities, ensuring compliance with relevant regulations and...
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Regulatory Affairs Specialist
2 weeks ago
Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $120,000Regulatory Affairs SpecialistThis is an exciting opportunity to join our team as a Regulatory Affairs Specialist. The successful candidate will be responsible for ensuring the continuity of supply via life cycle maintenance activities for our existing portfolio and supporting the registration of new medicines in Australia.The ideal candidate will have a...
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Regulatory Affairs Specialist
11 hours ago
Sydney, New South Wales, Australia beBeeRegulatory Full time $115,000 - $125,000Regulatory Affairs SpecialistThis is a rare opportunity to shape the regulatory and quality landscape for a growing organization.Key Responsibilities:Lead the development and execution of strategic regulatory submission plans and support new registrations.Liaise with regulatory bodies, acting as the primary contact for meetings, submissions, and query...
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Country Regulatory Affairs Specialist
8 hours ago
Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $120,000Country Regulatory Affairs SpecialistA key role in our organization is the Country Regulatory Affairs Specialist, who plays a critical part in ensuring that clinical trials are managed efficiently and effectively.The primary responsibilities of this position involve preparing, reviewing and coordinating local regulatory submissions (MoH, EC, additional...
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Senior Specialist Regulatory Affairs
2 weeks ago
Sydney, New South Wales, Australia ResMed Inc Full timeSenior Specialist Regulatory Affairs page is loadedSenior Specialist Regulatory AffairsApply locations Sydney, NSW, Australia time type Full time posted on Posted Yesterday job requisition id JR_043232About ResMedThe Sydney RPSD team leads regulatory strategy and delivery for physical products where ResMed Pty Ltd is the legal manufacturer, including masks,...
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Regulatory Affairs Specialist
2 days ago
Sydney, New South Wales, Australia beBeeRegulatory Full time $150,000 - $200,000Regulatory Affairs ExpertWe are seeking a skilled Regulatory Affairs Manager to build and lead our regulatory affairs team.The ideal candidate will have experience in software-as-medical-device and in-vitro diagnostic device regulations, as well as excellent interpersonal skills.Key responsibilities include preparing international regulatory submissions,...
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Senior Specialist Regulatory Affairs
2 weeks ago
Sydney, New South Wales, Australia ResMed Inc Full timeSenior Specialist Regulatory Affairs page is loadedSenior Specialist Regulatory AffairsApply locations Sydney, NSW, Australia time type Full time posted on Posted Yesterday job requisition id JR_043232About ResMedThe Sydney RPSD team leads regulatory strategy and delivery for physical products where ResMed Pty Ltd is the legal manufacturer, including masks,...
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Senior Specialist Regulatory Affairs
2 weeks ago
Sydney, New South Wales, Australia ResMed Full timeAbout Res Med The Sydney RPSD team leads regulatory strategy and delivery for physical products where Res Med Pty Ltd is the legal manufacturer, including masks, CPAP devices, ventilators, and accessories.The team supports both New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) across high-volume, global portfolios.As an individual...
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Regulatory Affairs Specialist
8 hours ago
Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $90,000 - $110,000Job OpportunityWe are seeking a talented professional to fill the role of Regulatory Affairs Associate. In this position, you will play a crucial part in enabling the ongoing registration of life-changing healthcare solutions for patients in Australia and New Zealand.Prepare, submit and manage the approval process of designated regulatory applications to the...
