Lead Regulatory Expert

6 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $140,000 - $150,000
Job Overview

As a Senior Regulatory Specialist, you will lead regulatory activities across international markets, focusing on APAC and EMEA regions.

This role involves partnering with cross-functional teams to drive product registrations, ensure compliance obligations are met, and support commercial initiatives. You will have the opportunity to make a tangible impact in a truly global environment.

Key Responsibilities
  • Coordinate regulatory submissions, renewals, and product lifecycle activities to maintain market access across multiple international regions.
  • Manage post-market compliance obligations either directly or in partnership with local representatives.
  • Provide timely regulatory input to support commercial initiatives such as tenders, product launches, and market expansion plans.
  • Act as the regulatory point of contact during audits and inspections from relevant authorities and certification bodies.
  • Keep internal stakeholders informed of changing regulatory requirements across supported markets ensuring alignment with global regulatory strategies.
  • Collaborate on the review and approval of customer-facing materials including marketing collateral and digital content.
  • Contribute to the continuous improvement of internal regulatory processes and systems.
Requirements
  • Tertiary qualifications in Regulatory Affairs, Engineering, Science, or a related discipline.
  • Strong stakeholder engagement skills with the ability to collaborate effectively across commercial, marketing, and senior leadership teams.
  • Confident communicator when working with external regulatory bodies notified bodies consultants and third-party representatives.
  • 3-5 years experience working with medical device regulations in APAC & EMEA markets.

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