Global Regulatory Affairs Quality Specialist

1 day ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $115,000 - $125,000

Job Opportunity:

Senior Associate – Global Regulatory Affairs

We are seeking a highly skilled Senior Associate to join our global regulatory affairs and quality team. As a key member of this team, you will play a vital role in post-market quality and regulatory operations.

  • Manage global post-market activities including complaint handling, vigilance reporting, and coordination of investigations with offshore manufacturing teams.
  • Develop and implement a centralized post-market surveillance process, including migration into a new enterprise quality management system.
  • Analyze and trend post-market data to support continuous improvement and risk mitigation initiatives.
  • Liaise with internal and external stakeholders globally to ensure alignment and quality communication.
  • Support internal and external audits, staff training, and development of controlled quality documentation.
  • Contribute to the development and maintenance of global procedures and metrics.

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