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About the Role

This role is for an experienced Quality Assurance & Regulatory Affairs professional to join Henry Schein, 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.

Responsibilities

• 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.

Requirements

• Solid foundation in Quality and/or Regulatory within medical devices.
• 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.

Work Type

• Work From Home
• Hybrid
• Onsite
• Field

Benefits

• Professional development and training opportunities
• Supportive team environment and fantastic culture
• Birthday leave
• $1500 Employee Referral Program
• Discounts on dental products and retail perks

About the Company

• 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.
• Over 90 years ago Henry Schein borrowed $500 to start a corner pharmacy in Queens, New York, nearly 30 miles from Melville, New York, where our corporate headquarters resides today.
• In the depths of the Great Depression, Henry and his wife Esther made a bold bet on their future all while living their values of helping health happen and caring for their team and the community they served.
• Their belief paid off far beyond what Henry and Esther might have dared to imagine in 1932.
• Henry Schein is now a Fortune 500 Company powered by a network of people and technology to be the world’s leading provider of health care products, services and solutions to office-based dental and medical practitioners.
• Since our founding we have stayed true to Henry and Esther’s values which has allowed us to evolve, expand, and grow our Company.
• Now serving more than 1 million customers in 33 countries and territories, the Company's network of trusted advisors provides more than 1 million customers globally with more than 300 valued solutions that help improve operational success and clinical outcomes.
• We invite you to join approximately 25,000 Team Schein Members, who are critical to our success and are at the core of our Team Schein Values as our founders would have wanted.
• We live those values by ensuring that our culture focuses on the wellness of our team, which we accomplish by providing a safe space for individuals to develop and contribute authentically, with opportunities to give back to society and the communities where we live and work.
• No matter the role you are seeking, we encourage you to come be a part of a team that makes the world a healthier place.

Equal Opportunity

• Henry Schein embraces diversity and is committed to providing equal opportunity to employees and applicants.
• If you are unable or limited in your ability to complete the application process, including the use or access of www.henryschein.com/careers, as a result of a physical or mental impairment, you can request reasonable accommodations.
• Please e-mail the appropriate email address below with the type of accommodation you are requesting.
• Please include your first and last name, phone number, position for which you are interested in applying and geographic location in your request.