Regulatory Compliance Specialist

2 days ago

Sydney, New South Wales, Australia beBeeExpert Full time $120,000 - $180,000
Regulatory Expertise Role

This key position oversees the management of regulatory activities within Australia and New Zealand.

Responsibilities:
  • Ensure compliance with objectives by managing product registration with regulatory authorities.
  • Coordinate with TGA and Medsafe for regulatory evaluations and processes.
  • Provide assessments on product and manufacturing changes related to regulatory actions.
  • Review and approve promotional materials for regulatory compliance.
  • Act as an expert on Australian and New Zealand Therapeutic Goods regulations.
  • Deliver training and guidance on regulatory topics to stakeholders.
  • Maintain knowledge of relevant Federal and State Regulations.
Essential Qualifications:
  • Science degree or equivalent qualification.
  • Minimum 7 years' experience in regulatory roles within medical devices or IVD industries.

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