Senior Regulatory Specialist
vor 2 Wochen
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/yr 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. 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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vor 3 Wochen
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Council of the City of Sydney, Österreich i-Pharm Consulting VollzeitRegulatory Affairs Specialist | 12-Month Contract Global Medical Devices Leader | APAC Focus | Sydney Step into a pivotal Regulatory Affairs role with a global, award‑winning medical devices company whose technologies are used by healthcare professionals in over 160 countries. This is a unique 12‑month contract opportunity to drive high‑impact APAC...
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Council of the City of Sydney, Österreich Australian Retirement Trust VollzeitSenior Regulatory Change and Compliance Specialist – Sydney or Brisbane Join Australian Retirement Trust in a role focused on regulatory change, compliance, and investment governance. The Senior Regulatory Change and Compliance Specialist will support the management of regulatory and internal policy compliance within our Investments business area. Why Join...
