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Regulatory Affairs Expert

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Sydney, New South Wales, Australia beBeeSpecialist Full time $120,000 - $160,000
Regulatory Affairs Expertise

As a key member of our Regulatory Affairs team, you will partner with cross-functional teams and global stakeholders to drive global submission readiness, change assessments, and technical documentation that meet diverse market requirements.

This role plays a critical part in authoring and reviewing submissions, guiding change assessments, and mentoring team members on the application of global regulations to high-volume, technically complex products.

The successful candidate will lead submission planning and execution, influence design documentation, and contribute to regulatory strategy for our core portfolio of devices.

  • Author and review global regulatory submissions including FDA 510(k), CE MDR, TGA ARTG, and Health Canada dossiers for masks, CPAP devices, and ventilators.
  • Interpret device-specific requirements (e.g., ISO 17510, ISO 80601, ISO 18562) and translate them into clear, well-supported regulatory documentation.
  • Align closely with Regional RA to ensure reusable, scalable submission approaches and consistent technical content.

Key qualifications include a Bachelor's degree in biomedical engineering, regulatory affairs, life sciences, or related discipline, 5+ years of experience in Regulatory Affairs within a regulated industry, and proven experience leading or coordinating global regulatory submissions.

The ideal candidate will have strong knowledge of ISO 13485, ISO 14971, design control frameworks, and relevant market-specific regulations, as well as excellent communication, project planning, and cross-functional influence skills.