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Henry Schein

Manager - Quality Assurance & Regulatory Affairs ANZ

Posted Yesterday
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Remote
Hiring Remotely in Australia
Mid level
Remote
Hiring Remotely in Australia
Mid level
Manage Quality and Regulatory activities, ensuring compliance with ISO 13485 and local TGA requirements while leading a team and improving quality systems.
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At Henry Schein, our culture, and our people (Team Schein Members) are at the core of our business, and we are enormously proud that we have been certified a Great Place to Work® 2025, which is our sixth consecutive year.

In Australia, Henry Schein is the leading supplier of dental solutions. Our Team Schein Members deliver the solutions that health care professionals rely on to improve the performance of their practice so they can improve the lives of patients.

Reporting to the Senior Director, Compliance and QARA Asia and ANZ, this is an exciting opportunity for an experienced Quality Assurance & Regulatory Affairs professional to join our business and make a meaningful impact, driving a culture committed to compliance, quality, and customer focus.

The position leads and coaches a team of specialists and is also hands-on in Quality Assurance and the Quality Management Systems.

Your Key Responsibilities:

  • You’ll be responsible for managing Quality and supporting Regulatory activities across the business, with a focus on keeping systems running smoothly and meeting local requirements.

  • Maintain and improve the Quality Management System (ISO 13485)

  • Support audit activities (internal and external)

  • Manage CAPA, document control, and continuous improvement processes

  • Assist with product-related quality activities, including investigations where required

  • Support regulatory processes, including maintaining product registrations

  • Ensure alignment with relevant local regulatory requirements (TGA)

  • Develop and maintain SOPs, policies, and procedures

  • Work cross-functionally with internal teams

Required Skills and Experience:

  • You’ll bring a solid foundation in Quality and/or Regulatory within medical devices, and be comfortable operating in a hands-on role.

  • Experience working with ISO 13485 and QMS environments

  • Exposure to TGA requirements and product registrations (ARTG)

  • Familiar with audits, CAPA, and quality processes

  • Able to take a practical, risk-based approach to compliance

  • Strong attention to detail and organisational skills

  • Comfortable working both independently and with internal stakeholders

Why You'll Love Working With Us

  • Professional development and training opportunities

  • Supportive team environment and fantastic culture

  • Birthday leave

  • $1500 Employee Referral Program

  • Discounts on dental products and retail perks

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