Job Description
Senior Regulatory Affairs Specialist - Medical Devices
Brisbane, QLD | Full-Time, Permanent
$125K + Super + 5-10% Bonus
Open to Candidates Willing to Consider Relocating to Brisbane
Medical Devices | Regulatory Affairs | Digital Health | Software & AI
The Opportunity
An exciting opportunity is available for an experienced Senior Regulatory Affairs Specialist to join a well-established organisation within the medical technology sector.
Working as part of a global Regulatory Affairs team, you will develop and execute regulatory strategies supporting innovative medical devices, software and AI-enabled technologies across the US, European and Australian markets.
This position would suit an experienced regulatory qualified looking to take ownership of complex regulatory activities while working closely with Engineering, Clinical, Quality and Product Development teams throughout the product lifecycle.
Candidates who are willing to consider relocating to Brisbane are encouraged to apply.
The Role
As a Senior Regulatory Affairs Specialist, your responsibilities will include:
Developing and executing regulatory strategies for new and existing medical devices and software
Leading and supporting global regulatory submissions
Preparing and supporting FDA 510(k), EU MDR and TGA submissions
Working closely with Engineering, Clinical, Quality and Product Development teams
Providing regulatory guidance throughout the product lifecycle
Advising on risk management, clinical evidence, product testing and labelling
Conducting regulatory assessments for product and design changes
Interacting with the FDA, Notified Bodies and TGA




Supporting regulatory pre-submission meetings
Supporting post-market activities, regulatory assessments, audits and CAPAs
Monitoring regulatory changes and advising stakeholders on new requirements
Contributing to regulatory strategies for emerging technologies, including AI and machine learning
About You
To be successful, you will ideally bring:
A Bachelor's degree in Science, Biomedical Engineering, Regulatory Affairs or a related discipline
5+ years' experience within medical devices, healthcare or a related regulated industry
Experience with regulatory submissions across the US and European markets
Strong knowledge of FDA regulations and EU MDR
Knowledge of ISO ***** and ISO *****
Excellent analytical and problem-solving capabilities
Strong written and verbal communication skills
Ability to work independently while collaborating across international and cross-functional teams
TGA experience will be highly regarded.
Experience with Software as a Medical Device (SaMD), digital health, AI or machine learning technologies would also be a strong advantage.
What's On Offer?
$125K + Super
5-10% bonus
Permanent, full-time hybrid opportunity
Brisbane-based position
Open to candidates willing to consider relocating to Brisbane
Exposure to international regulatory pathways
Work across creative medical devices, software and emerging technologies
Exposure to surgical instruments and navigation systems
Opportunity to influence products from development through to market launch
Collaboration with international Engineering, Clinical, Quality and Product teams
Strong opportunity for continued professional development

📌 Senior Regulatory Affairs Specialist (Queensland)
🏢 Lead Group
📍 Queensland