Medical Device Regulatory Specialist

6 days ago


Sydney, New South Wales, Australia beBeeMedicalDevice Full time $90,000 - $120,000
Regulatory Affairs Associate

This is an exciting opportunity to work in a Medical Device organisation as a Regulatory Affairs Associate.

The successful candidate will be responsible for managing a specific portfolio of medical device registrations across all classes, TGA and Medsafe.

  • Key responsibilities include:
    • Managing medical device registrations
    • Maintaining records and registrations in online platforms
    • Investigating labelling problems in quarantined products
    • Collaborating with internal teams and external partners to meet business launch deadlines
    • Ensuring compliance with regulatory frameworks
  • We are looking for someone who has experience working in the Medical Device industry in a regulatory affairs role.

The ideal candidate will have knowledge of Australian and New Zealand medicine and medical device regulatory requirements and processes.

We foster a culture of innovation, collaboration, and ownership.

You will have the opportunity to make a real impact on our organisation's success.



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