An exciting opportunity is available for an experienced
Senior Regulatory Affairs Specialist
to join a global medical technology organisation developing innovative solutions across
orthopaedics, surgical technologies, medical devices and digital health
.
Based in
Frenchs Forest with hybrid flexibility
, this position will join an established global Regulatory Affairs function and play an significant role in developing and executing regulatory strategies across
Australia, the US and Europe
.
The Role
Working closely with Engineering, Quality, Clinical and Product Development teams, you will support innovative medical technologies throughout the complete product lifecycle, from development and regulatory strategy through market approval and post-market activities.
Key responsibilities will include:
Develop and execute regulatory strategies for current and existing medical devices and software products
Lead and support
FDA 510(k), EU MDR and TGA submissions
Prepare and maintain regulatory and technical documentation
Provide regulatory guidance throughout product development and design changes
Support regulatory strategies for
SaMD, digital health and AI/ML-enabled technologies
Advise teams on risk management, clinical evidence, testing and labelling requirements
Work closely with Engineering, Clinical, Quality and Product Development stakeholders
Interact with
FDA, Notified Bodies and the TGA
and support pre-submission activities
Support post-market regulatory assessments, audits, CAPAs and product changes
Monitor global regulatory developments and assess their impact on products and the business




To be successful, you will ideally bring:
5+ years of Regulatory Affairs experience
within medical devices or a related regulated healthcare environment
Hands-on experience with international regulatory submissions
Strong knowledge of
FDA regulations and EU MDR
Experience with
FDA 510(k) submissions
Knowledge of
ISO ***** and ISO *****
TGA and Australian market-access experience would be highly regarded
Experience with
SaMD, medical device software or digital health
would be a strong advantage
Exposure to AI or machine-learning-enabled medical technologies would be advantageous
Degree qualification in Science, Biomedical Engineering, Regulatory Affairs or a related discipline
Strong communication skills and confidence working with international and cross-functional stakeholders
Why Consider This Opportunity?
This is an opportunity to move beyond purely maintenance-focused regulatory work and contribute to the development and commercialisation of
creative, technology-driven medical devices
.
You'll gain exposure to sophisticated
surgical technologies, navigation systems, software-enabled medical devices and emerging digital health solutions
, while working as part of an international regulatory and product development environment.
Working arrangement:
Hybrid
Industry:
Medical Devices / Orthopaedics / Digital Health
If you're an experienced medical device Regulatory Affairs qualified looking for greater exposure to
international submissions, product development and emerging medical technologies
, we'd be keen to hear from you.
#J-*****-Ljbffr

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