Regulatory Affairs AssociateOsseointegration International Pty Ltd — Sydney, NSW Permanent, full time | On-siteAbout usOsseointegration International designs and manufactures osseointegration implant systems for amputees.
We are an established medical device company headquartered in Sydney, with products supplied across multiple international markets.The roleWe are seeking a Regulatory Affairs Associate to expand our regulatory affairs function.
This is a process-focused role: you will help maintain the documentation, tracking, and coordination that keep complex regulatory submissions accurate, complete, and on schedule.
This is not a strategy role, and extensive regulatory experience is not required.
Our regulatory processes are already established, and you will be trained on them directly.
We are looking for someone with exceptional attention to detail and strong organisational discipline who wants to build a career in medical device regulatory affairs.Key responsibilitiesMaintain regulatory submission trackers and correspondence logsManage document control, including version management and approval statusCompile and format regulatory documentation to required standardsCross-reference claims, evidence,



and test reports to ensure traceability and consistencyCoordinate inputs from internal contributors and external consultants, following up on outstanding itemsSupport the preparation and tracking of responses to regulatory queriesMaintain technical documentation in an inspection-ready stateAbout youA background in science, engineering, biomedical, quality, or researchExceptional attention to detail and a low tolerance for loose ends or unresolved itemsStrong organisational and process-tracking skills, with the ability to manage a complex, deadline-driven workflowAble to read and follow technical and clinical documentationClear written communication and confidence in following up with contributors for inputsEarly-career candidates are encouraged to apply; prior regulatory experience is welcome but not essentialDesirableFamiliarity with medical device quality systems or ISO *****Exposure to international regulatory processes (e.g. TGA, FDA, CE/MDR)What we offerDirect mentorship from experienced management and meaningful ownership within our regulatory functionA clear progression path to Regulatory Affairs Specialist as the role developsSalary: $70,000–$90,000 + superannuation, commensurate with experience
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📌 Regulatory Affairs Associate (New South Wales)
🏢 Osseointegration International
📍 New South Wales