Quality Assurance and Regulatory Affairs Specialist

2 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $130,000
Quality Assurance and Regulatory Affairs

This is an exciting opportunity to join our team as a Quality Assurance and Regulatory Affairs professional.

  • Job Summary: We are seeking a highly skilled and experienced Quality Assurance and Regulatory Affairs professional to support our operations in Australia, New Zealand, and affiliates.
  • Key Responsibilities:
  1. Lead day-to-day QA and RA functions for Australia, New Zealand, and affiliates.
  2. Support compliance with ISO 13485 and local regulatory standards.
  3. Act as the local Subject Matter Expert for quality processes and risk assessments.
  4. Conduct internal audits and manage CAPAs, NCs, and quality records.
  5. Drive validation activities for custom-manufactured products at our Sydney facility.
  6. Collaborate with internal teams and corporate stakeholders across the globe.
  7. Train and support teams on quality and regulatory matters.
  8. Represent the business in local QA/RA meetings and interactions with TGA and other bodies.
Required Skills and Qualifications:

We are looking for someone who has a solid understanding of ISO 13485 and quality systems. The ideal candidate will have knowledge of internal auditing, CAPA, and validation processes.

  • Essential Skills and Qualifications:
    • ISO 13485 certification or equivalent.
    • Minimum 3 years' experience in a QA/RA role, preferably in medical devices.
    • Strong analytical and problem-solving skills.
    • Excellent communication and interpersonal skills.
    • Ability to work independently and collaboratively as part of a team.
Benefits:

As a member of our team, you will enjoy a competitive salary and benefits package, including access to ongoing training and development opportunities.

  • What We Offer:
    • Opportunity to work in a dynamic and fast-paced environment.
    • Competitive salary and benefits package.
    • Ongoing training and development opportunities.
Others:

Our company values diversity and inclusion, and we welcome applications from all qualified candidates.

The successful candidate will be required to undergo a thorough background check prior to commencement of employment.

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