Regulatory Affairs Associate

3 days ago

Sydney, Australia OneMD Pty Ltd Full time

Working with Class III consumbale devices - Can be located in any major city across Australia - Excellent company for career progression Our client is one of Australia’s leading independent medical device distributors. They are growing at a rapid rate after strategic acquisitions across the globe. Which in turn means a strong pipeline of new products. Position Overview: This position has been newly created due to the nature of the Regulatory affairs team expanding and becoming its own division. This is due to the expansion of the company **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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