Regulatory Compliance Specialist

5 days ago

Saint Leonards, Victoria, Australia beBeeCompliance Full time $100,000 - $120,000

Job Opportunity

We are seeking a highly skilled professional to join our team in Australia. The successful candidate will be responsible for ensuring compliance with Australian WHS legislation and quality standards, while also contributing to the broader organisational culture of accountability, risk management, and continuous improvement.

This is a high-impact opportunity for a professional seeking to apply their expertise in a smaller, more personable work environment, while still aligning with globally recognised quality systems.

Key Responsibilities

  • Ensure operations meet the requirements of the Work Health and Safety Act 2011 (Cth) and relevant state/territory-based WHS laws.
  • Monitor changes in Australian legislation, codes of practice, and industry standards, and provide advice regarding their implications.
  • Liaise with government agencies regulators and external consultants within Australia to ensure alignment and compliance.
  • Prepare the business for internal and external audits and represent the company in inspections and WHS compliance reviews conducted by Australian regulators.

Responsibilities

  • Develop and implement a local WHS strategy that supports the commitment to creating a safe and healthy workplace, aligned to Australian legal obligations and cultural expectations.
  • Design, implement, and manage a robust WHS Management System (WHSMS) appropriate to the business's risk profile and operations.
  • Conduct and document risk assessments, safety audits, site inspections, and compliance monitoring across all Australian operations.
  • Lead the development and delivery of local safety training, onboarding modules, toolbox talks, emergency drills, and employee education programs to ensure awareness and engagement with WHS responsibilities.
  • Act as a key escalation point for safety concerns and incidents, ensuring investigations are carried out and reported appropriately to regulators, with full documentation and response management in line with Australian standards.

Quality Assurance

  • Manage and maintain a Quality Management System (QMS) that supports compliance with ISO 9001, ISO 13485, and TGA expectations specific to the Australian medical device sector.
  • Write, update, and control all QA documentation to ensure it is owned and governed locally, including SOPs, work instructions, corrective actions, preventive actions (CAPA), deviation reports, and quality records.
  • Conduct internal QA audits and oversee external audit preparedness, coordinating with relevant business units to drive a culture of accountability and quality.
  • Work closely with senior management, operations, and service teams to ensure quality standards are embedded into all internal processes and external service delivery across Australia and New Zealand.

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