Executive Level 1
7 days ago
Executive Level 1
- $108,680 - $123,951
- Fairbairn ACT, Brisbane QLD, Parramatta NSW, Melbourne VIC
The TGA Medical Devices Auditors undertake assessment of manufacturers of medical devices for compliance with applicable regulatory requirements and product standards. These assessments are performed both as on-site audits at the manufactures' premises, and off-site reviews of applicable documentation. The TGA relies on audit outcomes from equivalent international regulatory agencies. In these cases, auditors assess key information to make a determination about the manufacturer's compliance with manufacturing quality requirements. TGA Medical Devices Auditors also conduct targeted audits in response to potential non-compliances with manufacturing quality requirements; are active in the International Medical Device Regulators Forum Medical Device Single Audit Program CMDSAP) and with confidence building activities with the European Commission.
**Mandatory Qualification**:
To be eligible for this position applicants must hold a tertiary qualifications in medicine, science or engineering (for example in microbiology, chemistry, computer hardware or software, material sciences or biomedical engineering) from an Australian institution or comparable overseas qualification.
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