Regulatory Affairs Specialist

1 day ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $150,000
Regulatory Affairs Specialist Opportunity

This role encompasses the provision of regulatory support and guidance across all stages of product life cycles.

Main Responsibilities
  • The position involves defining regulatory strategies for I&G products and services, encompassing global regulatory submissions including FDA 510(k), CE MDR, TGA ARTG, and Health Canada dossiers for Resmed products.
  • It also entails interpreting device-specific requirements and translating them into clear, well-supported regulatory documentation.
  • A key aspect is aligning closely with Regional RA to ensure reusable, scalable submission approaches and consistent technical content.
  • The role requires leading regulatory assessments of design and process changes—performing significance evaluations and preparing documentation updates.

As a Senior Regulatory Affairs Specialist – Incubation & Growth, you will lead regulatory assessments and develop regulatory strategies for products and services led by the Incubation and Growth team.

In this capacity, you will provide critical support to drive business growth and expansion while ensuring compliance with regulatory requirements.

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