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Regulatory Affairs Lead

2 weeks ago

Sydney, New South Wales, Australia i-Pharm Consulting Australia Pty Ltd Full time $90,000 - $120,000 per year

Are you a Regulatory Affairs professional ready to step into a lead role within a global, innovation-driven medical device company?

This is a fantastic opportunity to join a well-established business recognised for its strong culture and high-quality products used in healthcare settings worldwide.

In this role, you'll take the lead on regulatory activities across key international markets, with a particular focus on APAC and EMEA regions. You'll partner with cross-functional teams to drive product registrations, ensure compliance obligations are met, and support commercial initiatives.

Whether you're a seasoned Senior RA professional ready to step up, or an experienced lead seeking a new challenge, this position offers scope, visibility, and the chance to make a tangible impact in a truly global environment.

Responsibilities:

  • Lead and 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.
  • Operate in compliance with internal quality procedures and contribute to the ongoing development of quality standards.

Skills:

  • 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.

Apply directly now, or send your updated CV to Ben Byrne at - OR