Senior Regulatory Affairs Specialist

Drive Global Medical Device Innovation | Brisbane Lead the regulatory strategy behind next-generation medical technologies, software and AI-enabled healthcare solutions.

This is a rare opportunity to join a global medical technology organisation developing cutting-edge products that are transforming patient outcomes worldwide. Working across hardware, Software as a Medical Device (SaMD), and emerging AI-enabled technologies, you'll play a critical role in bringing innovative products to market across Australia, Europe and the United States

Why This Role?

Influence the global regulatory strategy for innovative medical devices and digital health technologies
Work on AI, machine learning and Software as a Medical Device (SaMD) products
Engage directly with international regulatory bodies including FDA, TGA and European authorities
Join a collaborative global team focused on innovation and improving patient outcomes
Be a key technical advisor throughout the full product lifecycle

The Opportunity

As the Senior Regulatory Affairs Specialist, you will lead and execute regulatory strategies that support the successful development, approval and commercialsation of advanced medical technologies. You'll work closely with engineering, clinical, quality and product development teams while acting as the regulatory subject matter expert across multiple global projects.

Key Responsibilities

Develop and execute global regulatory strategies for new and existing products
Prepare and manage regulatory submissions across the US, EU and Australian markets
Lead regulatory engagement with FDA, TGA and Notified Bodies
Provide strategic guidance throughout product development and commercialization
Support regulatory pathways for AI and machine learning-enabled medical technologies
Conduct regulatory impact assessments for product and process changes
Review technical documentation, risk management files and quality records
Support audits, CAPAs, post-market activities and ongoing compliance initiatives
Monitor evolving global regulatory requirements and advise the business accordingly

Essential

Degree in Science, Biomedical Engineering, Regulatory Affairs or a related discipline
Proven experience within medical devices, healthcare technology or a regulated life sciences environment
Strong knowledge of:
- FDA regulatory requirements
- EU MDR
- ISO 13485
- ISO 14971
- TGA regulations
Experience preparing and managing regulatory submissions in international markets
Exceptional stakeholder engagement and communication skills
Strong analytical, problem-solving and regulatory interpretation capabilities

Highly Regarded

Experience with Software as a Medical Device (SaMD)
Exposure to AI and machine learning-enabled healthcare products
Experience supporting global product launches
Background working in cross-functional product development environments

What's In It For You?

Work on market-leading medical technologies that genuinely improve lives
Global exposure across multiple regulatory jurisdictions
High-impact role with significant influence on business outcomes
Collaborative and innovation-focused culture
Opportunity to shape regulatory strategy for emerging healthcare technologies
Brisbane-based position with exposure to international stakeholders and projects

Aboriginal and Torres Strait Islander Peoples are encouraged to apply.
To apply please click apply or call Christine Iannarella on +61 7 3032 2235 for a confidential discussion.

Similar jobs

View more jobs