Manager – Quality Assurance, Regulatory Affairs

Role Overview

• Managing Quality and supporting Regulatory activities across the business
• Maintaining and improving the Quality Management System (ISO 13485)
• Supporting audit activities (internal and external)
• Managing CAPA, document control, and continuous improvement processes
• Assisting with product-related quality activities, including investigations where required
• Supporting regulatory processes, including maintaining product registrations
• Ensuring alignment with relevant local regulatory requirements (TGA)
• Developing and maintaining SOPs, policies, and procedures
• Working cross-functionally with internal teams

Requirements

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

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