Senior Regulatory Affairs Professional

6 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $144,000
Job Summary

This position plays a key role in driving the success of our regulatory strategy and submission execution. As a Senior Regulatory Affairs Specialist, you will lead submission planning and execution, influence design documentation, and contribute to regulatory strategy for our core portfolio of devices.

You will partner with cross-functional teams and global RA stakeholders to drive global submission readiness change assessments and technical documentation that meet diverse market requirements. This is an opportunity to work in a structured environment, apply high analytical rigor, and consistently deliver compliant high-quality documentation.

Key Responsibilities
  • Author and review global regulatory submissions including FDA 510k CE MDR TGA ARTG and Health Canada dossiers for masks CPAP devices and ventilators.
  • Interpret device-specific requirements e.g ISO 13485 ISO 14971 ISO 80601 ISO 18562 and translate them into clear well-supported regulatory documentation.
  • Align with Regional RA to ensure reusable scalable submission approaches and consistent technical content.
  • Lead regulatory assessments of design and process changes performing significance evaluations and preparing documentation updates.
  • Provide regulatory input on system-level verification biocompatibility human factors and labeling updates for high-volume products.
  • Collaborate with Engineering and Quality to resolve submission blockers and maintain lifecycle documentation compliance.
  • Represent RA in cross-functional design teams for products under Sydney legal manufacturer scope.
  • Engage early in project scoping and risk management activities to shape regulatory deliverables and timelines.
  • Act as a key point of contact for internal stakeholders on Sydney product regulatory requirements and interpretations.
  • Mentor junior team members in regulatory interpretation submission content quality and cross-functional collaboration.
  • Support onboarding and documentation standardization across the Sydney RPSD team.
  • Contribute to process improvements and advocate best practices in tools like Jira Confluence and RIMSYS.
Qualifications & Experience

Required:

  • Bachelor's degree in biomedical engineering regulatory affairs life sciences or related discipline.
  • 5+ years of experience in Regulatory Affairs within a regulated industry preferably medical devices.
  • Proven experience leading or coordinating global regulatory submissions e.g 510k CE Marking TGA ARTG.
  • Strong knowledge of ISO 13485 ISO 14971 design control frameworks and relevant market-specific regulations.
  • Excellent communication project planning and cross-functional influence skills.

Preferred:

  • Prior experience working with ResMed type devices CPAP ventilators masks accessories.
  • Familiarity with device-specific standards e.g ISO 17510 ISO 80601-2-70 IEC 60601 ISO 18562.
  • Hands-on experience with submission platforms and document control tools e.g RIMSYS Jira Confluence.
  • Experience providing peer review or coaching in a cross-regional or matrixed environment.
Who We're Looking For

We are seeking a technical translator and regulatory mentor who thrives in structured environments applies high analytical rigor and consistently delivers compliant high-quality documentation. You bring people with you clarify the complex and help us meet regulatory obligations while bringing innovation to market faster.

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