Senior Regulatory Affairs Associate – Medical Devices

Sydney | Permanent Full-Time

NES Fircroft is seeking a passionate and driven Senior Regulatory Affairs Associate to join a high-performing regulatory team within a global medical device leader. If you're enthusiastic about improving patient outcomes through innovative medical technologies, this is your chance to make an impact.

The Role

• Lead and prepare Class III and TGA conformity assessment applications
• Manage change notifications, license renewals, and annual reports
• Provide strategic regulatory guidance during product transfers and acquisitions
• Collaborate with cross-functional teams to meet TGA, Medsafe, and global requirements
• Mentor junior RA team members and contribute to continuous process improvement
• Build strong relationships with regulatory bodies and industry stakeholders

You

• 5 years' experience in Regulatory Affairs within medical devices
• Solid understanding of Class III submissions and TGA regulatory landscape
• Degree in Science, Engineering, Biomedical or related field
• Strong technical writing, problem-solving, and communication skills
• Team-oriented, proactive, and adaptable to fast-paced environments
• Knowledge of international regulations (FDA, EU MDR) desirable

Why Apply?

• Be part of a passionate and collaborative team
• Career growth with global exposure
• Competitive salary package and extensive benefits
• Access to volunteer days, self-development programs, and wellbeing initiatives

Ready to take your regulatory career to the next level? Apply now to explore this exciting opportunity with NES Fircroft.

With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.