Senior Regulatory Compliance Specialist

6 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $180,000 - $200,000
About the Role
Are you a detail-driven and analytical professional looking to make a meaningful impact in the regulatory affairs field? As a Senior Specialist Regulatory Affairs, you will play a critical role in driving submission readiness, change assessments, and technical documentation that meet diverse market requirements. This is an exciting opportunity to leverage your technical expertise and passion for compliance to drive business success.

Job Description
We are seeking a highly skilled and experienced professional to lead submission planning and execution, influence design documentation, and contribute to regulatory strategy for our core portfolio of devices. You will be responsible for authoring and reviewing global regulatory submissions, interpreting device-specific requirements, and translating them into clear, well-supported regulatory documentation. Additionally, you will align closely with Regional RA to ensure reusable, scalable submission approaches and consistent technical content. Key responsibilities include:
  • Author and review global regulatory submissions including FDA 510(k), CE MDR, TGA ARTG, and Health Canada dossiers.
  • Interpret device-specific requirements and translate them into clear, well-supported regulatory documentation.
  • Align closely 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 labelling 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 and engage early in project scoping and risk management activities.

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