Senior Specialist

6 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $115,000 - $125,000
Global Quality and Regulatory Affairs Expert

The role of a Senior Associate – Global Regulatory Affairs is to contribute significantly in post-market quality and regulatory operations, ensuring compliance, facilitating continuous improvement, and implementing robust product lifecycle management strategies.

  • Responsible for global post-market activities including complaint handling, vigilance reporting, and coordination of investigations with offshore manufacturing partners.
  • Develop and implement a centralized post-market surveillance process, integrating migration into a new eQMS system.
  • Analyse and trend post-market data to support continuous improvement and risk mitigation initiatives.
  • Collaborate 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.

The ideal candidate will have a minimum of 5 years' experience in quality and regulatory affairs within the medical device sector.

Requirements
  • Minimum 5 years' experience in quality and regulatory affairs within the medical device sector.
  • Proven experience managing post-market surveillance, complaint handling, and vigilance reporting.
  • Strong understanding of ISO 13485, TGA, FDA, MDR and quality systems principles.
  • Demonstrated ability to work cross-functionally across regions (e.g. Operations, R&D, Sales & Marketing).
  • Hands-on experience with eQMS platforms highly regarded.
  • Excellent problem-solving, communication, and data analysis skills.
  • Degree in Life Sciences, Engineering or related discipline (equivalent experience considered).

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