Product Compliance Engineer

About the role

In this role, you will be the primary owner of product technical documentation and regulatory records, ensuring they are complete, accurate, current, and audit-ready at all times. You will work closely with engineering, product development, marketing, sales, and supply chain teams to embed regulatory requirements into product design, release, and ongoing maintenance.

Role Title: Product Compliance Engineer

Location: Moorebank, New South Wales, Australia

Hours: Monday – Friday, Full Time Permanent

Reporting: Manager – Product Quality and Engineering

Essential Skills & Qualifications

• Minimum 5 years’ experience in a regulatory affairs, compliance, or quality role
• A tertiary qualification in Engineering (mechanical, biomedical, electrical, or similar, or a relevant Science discipline
• Experience in the healthcare or medical devices sector (strongly preferred)
• Knowledge of TGA, ACCC, EESS, or similar product safety and consumer compliance requirements
• Experience in authoring and maintaining technical files, managing compliance documentation systems/databases and supporting post-market surveillance
• Excellent written and verbal communication skills for authoring and maintaining technical files and regulatory documentation
• Strong understanding of medical device regulatory frameworks for Class I medical devices

Duties & Responsibilities

• Author, maintain, and control product technical files in accordance with applicable global regulatory requirements (e.g. ARTG, Medsafe, MHRA)
• Develop and maintain core compliance documentation
• Review product collateral and technical documentation to ensure alignment with regulatory and compliance requirements
• Support the ongoing development, improvement, and scalability of the company’s compliance systems and processes
• Ensure documentation and records are audit-ready with accurate version control, traceability and document control in line with internal polices and quality system requirements
• Review, assess, and trend customer complaints to identify potential quality, safety, or compliance issues
• Support regulatory enquiries, inspections, and investigations in collaboration with senior stakeholders

Benefits

• Employee discounts on Aidacare health equipment products and services
• Quarterly incentive scheme (delete if casual or not applicable)
• Employee Assistance Program to support mental wellness
• Benefits package includes discounts for retail, insurance, gym and more
• Comprehensive training program to equip you with the necessary skills and knowledge

How to apply

Please submit your application by clicking "Apply Now". Join our team at Aidacare and help us create memorable experiences for our valued customers!

About the company

Aidacare is one of the leading players in the Healthcare Equipment Industry, we pride ourselves on our commitment to excellence, innovation, and customer satisfaction. Aidacare has 1,300 staff and over 90 locations across all states and territories in Australia.