Medical Product Registration Specialist

2 days ago

Sydney, New South Wales, Australia beBeeCompliance Full time $90,000 - $140,000
Regulatory Affairs Specialist

We are seeking a skilled Regulatory Affairs Specialist to support the ongoing registration of life-changing healthcare solutions in Australia and New Zealand.

This role is responsible for ensuring compliance within the regulatory framework and collaborating with cross-functional stakeholders to maintain product portfolio compliance.

Key Responsibilities:
  • Prepare, submit, and manage designated regulatory applications to the TGA and Medsafe.
  • Develop and implement optimized regulatory strategies to ensure products remain registered and labels are optimized throughout their lifecycle.
  • Develop expertise in local operational processes and systems associated with product information, artwork, planned, and ongoing registration activities.
  • Collaborate with Regulatory Affairs Partners and other cross-functional stakeholders to ensure the entire product portfolio remains fully compliant with external and internal requirements.
  • Work with internal stakeholders to develop and optimize new and existing internal processes and systems.
  • Provide regulatory input into pre-market, post-market, and business activities as required.
  • Assist with internal and external audits and support records management.
Requirements:
  • Tertiary qualification in a life sciences field.
  • 2 or more years' previous experience in a regulatory affairs (preferred) or compliance role in the pharmaceutical, biotechnology, or related industry, within the Australian, New Zealand, or other relevant markets.
  • A foundational understanding of the Australian and New Zealand Pharmaceutical regulatory environments.
  • A strong aptitude and genuine interest in learning, using, and coaching others on complex systems.
  • Advanced knowledge of Microsoft Office suite: Word, Excel, PowerPoint, and Google suite.
  • Knowledge of the potential utility of AI and a continuous learning mindset.
  • Very good attention-to-detail, interpersonal, communication, analytical, and problem-solving skills.
  • Good organizational and time management skills.

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