Senior Regulatory Affairs Specialist

Lead Group; Sydney; Hybrid; AUD 120,000 - 130,000; Full time

Benefits offered by this job

Superannuation

Bonus 5-10%

Hybrid work arrangement

Job summary

Lead Group in Brisbane seeks a Senior Regulatory Affairs Specialist to drive regulatory strategy for medical devices, software and AI-enabled technologies across US, EU and AU markets.

Work with Engineering, Clinical, Quality and Product Development teams through the lifecycle, coordinating submissions and regulatory guidance while fostering international collaboration. Relocation to Brisbane is encouraged for the right candidate.

Qualifications

• 5+ years' experience in medical devices or 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 SaMD, digital health or AI technologies would be a strong advantage

Responsibilities

• Develop regulatory strategies for medical devices and software
• Lead and support global regulatory submissions
• Prepare FDA 510(k), EU MDR and TGA submissions
• Collaborate with Engineering, Clinical, Quality and Product Development teams
• Provide regulatory guidance throughout the product lifecycle
• Advise on risk management, clinical evidence, product testing and labeling
• Conduct regulatory assessments for product and design changes
• Interact with FDA, Notified Bodies and TGA
• Support regulatory pre-submission meetings
• Support post-market activities and regulatory audits/CAPAs
• Monitor regulatory changes and advise stakeholders on new requirements
• Contribute to regulatory strategies for AI/ML technologies

Skills

Regulatory strategy

Regulatory submissions

FDA regulations

EU MDR

ISO 13485

ISO 14971

Analytical thinking

Communication skills

Independent work

Cross-functional collaboration

Education

Bachelor's degree in Science/ Biomedical Engineering/ Regulatory Affairs

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 experiencedSenior Regulatory Affairs Specialistto 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 innovativemedical devices, software and AI-enabled technologiesacross 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 supportingFDA 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 withFDA, 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, includingAI and machine learning

About You

• A Bachelor’s degree inScience, Biomedical Engineering, Regulatory Affairsor a related discipline


• 5+ years' experiencewithin medical devices, healthcare or a related regulated industry


• Experience with regulatory submissions across theUS and European markets


• Strong knowledge ofFDA regulations and EU MDR


• Knowledge ofISO 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 withSoftware as a Medical Device (SaMD), digital health, AI or machine learning technologieswould 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.