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Regulatory Affairs Director

1 month ago

Sydney, New South Wales, Australia On Q Recruitment Full time
About On Q Recruitment

On Q Recruitment is proud to partner with an ASX-listed medical device company in their search for a Senior Manager – Global Regulatory Affairs & Quality Assurance.

Job Overview

This is a permanent, full-time position that offers excellent work-from-home flexibility. As a key member of the leadership team, you will play a pivotal role in driving quality assurance activities across the company's global operations.

Key Responsibilities
  • Lead Cultural Transformation: Embed quality into the core of all processes and foster a proactive, collaborative approach across departments.
  • Ensure Global Compliance: Oversee regulatory and quality functions, ensuring alignment with ISO 13485, GMP, TGA, FDA, CE, and other global standards.
  • Elevate Manufacturing Operations: Provide regulatory guidance and quality oversight for the overseas manufacturing facility, supporting audits, resolving quality issues, and mentoring the on-site team.
  • Drive Strategic Initiatives: Support the global transition to an electronic QMS.
Requirements
  • A Degree in Life Sciences
  • A minimum of 8 years of quality assurance and/or regulatory affairs experience in the medical device industry.
  • Previous quality experience within a manufacturing environment.
  • The ability to influence stakeholders, build cross-functional collaboration, and drive accountability.
  • A proactive, hands-on approach, thriving in dynamic, fast-paced environments.
  • Previous line management experience.
Estimated Salary Range:

$120,000 - $160,000 per annum, depending on experience and qualifications.