About the role:

In this role, you will oversee the day-to-day operations of regulatory affairs, ensuring full compliance with regulatory submission requirements. You will be responsible for preparing and managing documentation for new product submissions and updates to existing approvals.

Key Responsibilities:

• Prepare and submit regulatory documentation for the Australia and New Zealand (ANZ) market
• Review and approve marketing and promotional materials to ensure regulatory compliance
• Collaborate cross-functionally to support new product launches and market expansions
• Liaise with regulatory authorities regarding submission projects and approvals
• Develop and submit reimbursement applications
• Effectively manage multiple projects and competing priorities to optimize time and resources
• Maintain and update product registration and listing databases on a regular basis
• Manage change control processes for approved products, including related regulatory submissions
• Monitor updates from TGA and MEDSAFE, ensuring the organization remains informed and compliant with evolving regulations

About the Requirements

This specialist position will suit an experienced RA professional from within the medical devices industry.

• Bachelor’s Degree required, preferably in a Science or Engineering discipline. 
• Minimum 3+ years of RA experience within a medical device company
• Exposure to Orthopaedic products would be advantageous
• Working experience with class III medical device submissions
• Clear knowledge and understanding of TGA and MEDSAFE regulations
• Strong interpersonal, English oral and written communication skills required.
• Ability to work in fast paced environment and handle multiple tasks and requests. 
• Ability to comprehend orthopaedic technical/engineering/medical terminology or can reference literature for understanding.