Regulatory Affairs Specialist

21 hours ago


Ryde, Australia beBeeRegulatory Full time $85,000 - $105,000
Job Title: Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs Specialist to join our team.

  • Assess and report on complaints received in Australia and New Zealand for regulatory purposes.
  • Coordinate responses to regulator inquiries regarding post-market activities.
  • Support the submission and tracking of product complaints as required.
  • Perform reconciliation activities for customer-oriented programs as needed.
  • Contribute to improvement projects across the RA function.
  • Support key regulatory activities for medical devices, including preparation of submissions to regulatory authorities, processing requests for certificates of free sale, responding to internal requests for registration information, management of reporting requirements for products supplied under special access schemes, and review of promotional materials.
  • Coordinate CPDS tracking and maintenance as required.
  • Manage the Registration Master File and submit required paperwork to Global RA.
  • Investigate and resolve local CAPAs as a certified investigator.

Required Skills:

  • University degree in Science, Pharmacy, Engineering, or related field.
  • 3-5 years' experience working in a similar role for a medical device company.
  • Knowledge of ANZ regulatory requirements and ISO standards for Quality Management Systems (ISO 13485 & ISO 9001).
  • Strong written and verbal communication skills.
  • Proficient in MS Office packages (Excel, Outlook, Word, PowerPoint).
  • Continuous improvement mindset with strong work ethics.


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