Regulatory Strategy and Delivery Expert

10 hours ago

Sydney, New South Wales, Australia beBeeExpertise Full time $120,000 - $150,000
Regulatory Strategy and Delivery Expert

This role requires a high level of expertise in regulatory strategy and delivery, specifically for physical products.

  • Author and review global regulatory submissions including FDA 510(k), CE MDR, TGA ARTG, and Health Canada dossiers for masks, CPAP devices, and ventilators.

The ideal candidate will have strong knowledge of device-specific requirements (e.g., ISO 17510, ISO 80601, ISO 18562) and be able to translate them into clear, well-supported regulatory documentation.

Responsibilities:
  • Lead regulatory assessments of design and process changes-performing significance evaluations and preparing documentation updates.
  • Collaborate with cross-functional teams to resolve submission blockers and maintain lifecycle documentation compliance.

Key qualifications include a Bachelor's degree in biomedical engineering, regulatory affairs, life sciences, or related discipline, as well as 5+ years of experience in Regulatory Affairs within a regulated industry (preferably medical devices).

The successful candidate will play a critical role in authoring and reviewing submissions, guiding change assessments, and mentoring team members on the application of global regulations to high-volume, technically complex products.

This is an excellent opportunity to bring people with you, clarify the complex, and help meet regulatory obligations while getting innovation to market faster.

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