Senior Regulatory Specialist

5 days ago

Sydney, New South Wales, Australia I-Pharm Consulting Full time

Overview 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.Base pay range A$140,000.00/yr - A$150,000.00/yrResponsibilities 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.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 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.Application Apply directly now, or send your updated CV to Ben Byrne at OR #J-18808-Ljbffr

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