Medical Device Compliance Specialist

1 week ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $140,000 - $150,000
Regulatory Affairs Lead

This is a key role within a global medical device organization, ideal for a Regulatory professional seeking a new challenge.

The successful candidate will lead regulatory activities across international markets, with a focus on APAC and EMEA regions, partnering with cross-functional teams to drive product registrations and ensure compliance obligations are met.

Responsibilities include:

  • Leading and coordinating regulatory submissions, renewals, and product lifecycle activities to maintain market access across multiple international regions.
  • Managing post-market compliance obligations, either directly or in partnership with local representatives.
  • Providing timely regulatory input to support commercial initiatives such as tenders, product launches, and market expansion plans.
  • Acting as the regulatory point of contact during audits and inspections from relevant authorities and certification bodies.
  • Keeping stakeholders informed of changing regulatory requirements across supported markets, ensuring alignment with global regulatory strategies.
  • Collaborating on the review and approval of customer-facing materials, including marketing collateral and digital content.
  • Contributing to the continuous improvement of internal regulatory processes and systems.
  • Operating in compliance with internal quality procedures and contributing to the ongoing development of quality standards.

Required skills and qualifications:

  • 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 communication 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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