Expert Regulatory Affairs Professional

5 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $140,000

Regulatory Affairs Expert Wanted

About the Role

We are seeking a highly skilled Regulatory Affairs expert to lead our submission planning and execution. This role will involve influencing design documentation, contributing to regulatory strategy, and ensuring compliance with market-specific regulations.

Key Responsibilities
  • Develop and review global regulatory submissions for medical devices, 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.
  • Collaborate with cross-functional teams 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.
  • Represent RA in design teams and collaborate with Engineering and Quality to resolve submission blockers and maintain lifecycle documentation compliance.
  • Engage early in project scoping and risk management activities to shape regulatory deliverables and timelines.
Qualifications & Experience
  • 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.
  • Strong knowledge of ISO 13485, ISO 14971, design control frameworks, and relevant market-specific regulations.

What We Offer

A challenging and rewarding role with opportunities for growth and development in a dynamic industry.

Why Join Us?

As a key member of our team, you will have the opportunity to make a real impact on the development and approval of medical devices.

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