Senior Regulatory Affairs Specialist

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 professional 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 13485 and ISO 14971
• 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 innovative 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

Interested?
If you’re an experienced Regulatory Affairs professional looking for your next opportunity within the medical technology industry – whether you’re currently based in Brisbane or willing to consider relocating – we’d love to hear from you.
  
Apply now with your CV for a confidential discussion.