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Regulatory Affairs Associate
1 week ago
- Can be located in any major city across Australia
- Excellent company for career progression
Position Overview:
This position has been newly created due to the nature of the Regulatory affairs team expanding and becoming its own division.
Responsibilities:
- Prepare and submit products for TGA Registration and/or Medsafe approval.
- Liaise with Suppliers (and/or subcontractors) to gain all product information required to register and list products.
- Maintain and keep up to date record keeping of same
- Ensure TGA / Medsafe Registration and Manufacturers' evidences are kept current.
- Coordinate TGA product Recalls or Device Incident Reporting when they occur & manage communication of same.
- Provide regulatory bodies with required reports/reviews (for example, annual reporting, post market reviews & general enquiries).
- Assist with provision of ARTG Certificates for Tender / Quote / Sales requirements.
Desired experience:
- Minimum 2 years of Medical Devices experience in Regulatory affairs
- Experience in TGA submission stand alone
- Bachelor's degree qualified (science, business, nursing etc.)
What's on offer:
- Competitive Base salary + Super
- Can be located in any major city across Australia
- Bonus available
- Strong product pipeline working with Class III devices.
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