Medical Device Regulatory Affairs Expert

1 day ago

Sydney, New South Wales, Australia beBeeCompliance Full time $70,000 - $120,000
Regulatory Compliance Specialist

We are seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our organization, you will play a critical role in ensuring compliance with regulatory requirements for Class III consumable devices.

This exciting opportunity offers the chance to work with a leading medical device distributor in Australia, providing excellent career progression opportunities and a strong product pipeline.

Key Responsibilities:

  • Prepare and submit products for registration and approval.
  • Liaise with suppliers to gain all necessary information required for registration and listing.
  • Maintain up-to-date records and ensure current TGA/Medsafe registration and manufacturer evidence.
  • Coordinate recalls and manage communication with regulatory bodies.
  • Provide regulatory bodies with required reports and reviews.
  • Assist with provision of ARTG certificates for tender/quote/sales requirements.

Desired Qualifications:

  • Minimum 2 years of experience in medical devices regulatory affairs.
  • Experience in TGA submission.
  • Bachelor's degree qualified in a relevant field.

What's on Offer:

  • Competitive base salary and superannuation benefits.
  • Location flexibility across major Australian cities.
  • Bonus available.
  • Strong product pipeline working with Class III devices.

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