Senior Regulatory Affairs Specialist

1 day ago

Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $100,000 - $140,000

We are seeking a skilled professional to join our Regulatory Affairs team as a Senior Associate. In this role, you will be responsible for managing end-to-end regulatory submissions, including interactions with the Therapeutic Goods Administration (TGA). You will lead regulatory strategy and compile technical files, primarily adapted from EU documentation.

Key Responsibilities
  • Manage regulatory submissions, ensuring timely and compliant pre-market submissions for the ANZ region.
  • Develop and implement regulatory strategies to support high-priority product portfolios.
  • Compile technical files, adapting from EU documentation as required.
  • Evaluate the regulatory impact of product and process changes.
  • Review promotional and advertising materials for compliance.
  • Collaborate with cross-functional teams to ensure regulatory support is provided across the organization.
Requirements
  • Tertiary qualification in a scientific or healthcare-related discipline.
  • A minimum of 3 years' experience in Regulatory Affairs, specifically in medical devices.
  • Strong technical writing skills, particularly in regulatory files.
  • Experience working on TGA submissions and promotional material reviews.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and manage priorities in a fast-paced environment.
Benefits of Working with Us

We offer a dynamic work environment that values innovation, autonomy, and open communication. Our team thrives on big-picture thinkers who dive deep into detail, with a supportive leadership style suited to self-managed workloads.

About the Opportunity

This is an exciting opportunity to contribute to the growth of our business by providing regulatory expertise and support to our cross-functional teams. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply.

  • Senior Specialist Regulatory Affairs

    19 hours ago

    Sydney, New South Wales, Australia ResMed Inc Full time

    Senior Specialist Regulatory Affairs page is loaded## Senior Specialist Regulatory Affairslocations: Sydney, NSW, Australiatime type: Full timeposted on: Posted Todayjob requisition id: JR\_043232**About ResMed**The Sydney RPSD team leads regulatory strategy and delivery for physical products where ResMed Pty Ltd is the legal manufacturer, including...

  • Senior Specialist Regulatory Affairs

    11 hours ago

    Sydney, New South Wales, Australia ResMed Inc Full time

    Senior Specialist Regulatory Affairs page is loaded## Senior Specialist Regulatory Affairslocations: Sydney, NSW, Australiatime type: Full timeposted on: Posted Todayjob requisition id: JR/_043232**About ResMed**The Sydney RPSD team leads regulatory strategy and delivery for physical products where ResMed Pty Ltd is the legal manufacturer, including...

  • Senior Specialist Regulatory Affairs

    3 weeks ago

    Sydney, New South Wales, Australia ResMed Inc Full time

    Senior 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,...

  • Senior Regulatory Affairs Specialist

    1 day ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $140,000

    Job DescriptionThe Regulatory Affairs team plays a crucial role in shaping regulatory strategy and submission execution for physical products. As a Senior Specialist, you will lead submission planning and execution, influencing design documentation and contributing to regulatory strategy.You will collaborate across functions to drive global submission...

  • Senior Specialist Regulatory Affairs

    1 day ago

    Sydney, New South Wales, Australia Resmed Full time

    OverviewThe Sydney Regulatory Affairs team leads regulatory strategy and submission execution for physical products where ResMed 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....

  • Senior Specialist Regulatory Affairs

    2 days ago

    Sydney, New South Wales, Australia Resmed Full time

    OverviewThe Sydney Regulatory Affairs team leads regulatory strategy and submission execution for physical products where ResMed 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....

  • Senior Specialist Regulatory Affairs

    3 weeks ago

    Sydney, New South Wales, Australia ResMed Inc Full time

    Senior 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,...

  • Regulatory Affairs Specialist

    1 day ago

    Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $90,000 - $110,000

    Regulatory Affairs SpecialistWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to support our organization in delivering regulatory submissions on time.Key Responsibilities:Deliver regulatory submissions within required timeframes;Ensure databases and systems are accurate and current by drafting, updating, reviewing and...

  • Senior Specialist Regulatory Affairs

    2 weeks ago

    Sydney, New South Wales, Australia ResMed Full time

    About 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...

  • Senior Specialist Regulatory Affairs

    4 days ago

    Sydney, New South Wales, Australia ResMed Full time

    About ResMedThe Sydney RPSD team leads regulatory strategy and delivery for physical products where ResMed 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...