Manager - Quality Assurance & Regulatory Affairs
Henry Schein Regional Trust
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