Product Regulatory Strategist

6 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $140,000 - $160,000
Job Summary:

The Regulatory Product Strategy team is responsible for leading regulatory affairs initiatives for product development projects. This includes New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) projects across masks, therapy devices, and their accessories.

This role leads a team of regulatory professionals and works closely with engineering, project management, quality, and global partners to define and execute regulatory strategies, deliver submission-ready documentation, and ensure cross-regional compliance.

Main Responsibilities:

  • Lead RA strategy and delivery for NPI projects
  • Define regulatory pathways and ensure submission planning aligns with market access timelines and business needs
  • Guide the development of design input requirements, verification strategies, and risk documentation that meet global regulatory expectations

Key Qualifications:

  • Bachelor's degree in biomedical engineering, life sciences, regulatory affairs, or a related discipline
  • 6+ years in Regulatory Affairs, with 2+ years in a leadership or mentoring capacity
  • Proven experience supporting device submissions (e.g., FDA 510(k), CE MDR)

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