Quality Assurance and Regulatory Affairs Associate

6 days ago

Sydney, New South Wales, Australia beBeeCompliance Full time $120,000 - $130,000
Regulatory Compliance Specialist Role

A key opportunity for a detail-oriented and self-motivated individual with expertise in quality systems to support and elevate our operations.

We're seeking a skilled professional with knowledge of ISO 13485 to lead day-to-day regulatory compliance functions, ensure adherence to standards, and collaborate with internal teams across the globe.

Key Responsibilities:

  • Lead day-to-day regulatory compliance functions for Australia, New Zealand, and affiliates.
  • Ensure compliance with ISO13485 and local regulatory standards.
  • Act as the local Subject Matter Expert for quality processes and risk assessments.
  • Conduct internal audits and manage CAPAs, NCs, and quality records.
  • Drive validation activities for custom-manufactured products at our facility.
  • Collaborate with internal teams and corporate stakeholders across the globe.

Requirements:

  • Has a solid understanding of ISO 13485 and quality systems.
  • Knows their way around internal auditing, CAPA, and validation processes.
  • Is confident, detail-oriented, and self-motivated.
  • Communicates effectively with stakeholders at all levels.
  • Has 3+ years' experience in a QA/RA role, ideally in medical devices.

Benefits of this role include:

  • Opportunity to work on high-profile projects.
  • Chance to develop skills in quality assurance and regulatory compliance.
  • Collaborative and dynamic work environment.
  • Professional growth and development opportunities.

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