Administrative Support Specialist

11 hours ago

Macquarie Park, Australia MAYDAY Recruitment Group Full time
Unique Opportunity in Medical Devices

We are seeking a proactive and self-motivated Administration Assistant to support our client in the Macquarie Park area.

This role offers work-from-home flexibility (1-2 days per week in the office) and will see you supporting a team of professionals by completing administrative tasks surrounding TGA regulations.

Key Responsibilities:
  • Follow organisational procedures and all other regulatory requirements when completing your duties
  • Support with the execution of corrective actions surrounding product Recall and Non-Recall, including liaison with internal and external stakeholders
  • Assist with Regulatory reporting and submitting device incident reports where required, in accordance with TGA and similar regulations
  • Respond to Regulatory Inquiries from TGA and other regulatory bodies
  • Managing internal stakeholder relationships, particularly surrounding complaints and recalls
  • Coordinate the return of products where appropriate
  • Analyse data of all inventory reports
  • Prepare and release regular reports associated with regulatory actions and post-market reviews
Requirements:
  • Knowledge and understanding of applicable external medical device regulatory standards including TGA, MedSafe and ISO
  • Demonstrated organisational and administrative skills such as record keeping and data entry
  • Analytical skills and computer competency, with the ability to utilise new systems quickly
  • Ability to multitask and manage a wide variety of tasks and competing deadlines
  • Strong communication and interpersonal skills, both written and verbal
  • Candidates must be able to commit to at least the required duration of the assignment
  • Candidates must be happy attending the office in Macquarie Park when required

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