Quality, Regulatory & Compliance Manager - Medical Technology

About the role

Talent Aligned is recruiting, on behalf of an established Australian-owned pioneer in specialized healthcare and cleaning technology, a strategic Quality, Regulatory & Compliance Manager based in Adelaide. The role owns the end-to-end quality and compliance strategy, embedding rigorous processes across business operations, warehouse functions, R&D, design and service engineering.

Key responsibilities

• Design, map and implement operational processes, checklists and Service Level Agreements (SLAs) across all departments, ensuring cross-functional clarity and accountability.
• Oversee quality control frameworks, including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) inspection processes.
• Partner with R&D, product design, manufacturing, warehouse operations and service engineering to maintain high quality standards.
• Ensure full adherence to medical device standards, industry regulations and internal compliance benchmarks.
• Train internal teams, monitor SLA performance and drive a culture of continuous improvement.

Required profile

• Extensive experience in quality assurance, regulatory affairs or compliance management in a regulated manufacturing, medical device or engineering environment.
• Proven track record designing, documenting and implementing operational processes, workflows, checklists and SLAs.
• Deep familiarity with IQ, OQ and PQ validation protocols.
• Strong stakeholder management and communication skills, able to lead cross-functional teams.
• Relevant tertiary qualification in Quality Management, Engineering, Science or a related discipline.

The role offers ownership of quality and compliance architecture, direct influence from R&D through to service delivery, and a stable, Australian-owned employer. Applications are submitted through Talent Aligned, which handles them confidentially.