Regulatory Affairs Associate

Osseointegration International Pty Ltd — Sydney, NSW Permanent, full-time | On-site

About us

Osseointegration 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 role

We 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 responsibilities

- Maintain regulatory submission trackers and correspondence logs
- Manage document control, including version management and approval status
- Compile and format regulatory documentation to required standards
- Cross-reference claims, evidence, and test reports to ensure traceability and consistency
- Coordinate inputs from internal contributors and external consultants, following up on outstanding items
- Support the preparation and tracking of responses to regulatory queries
- Maintain technical documentation in an inspection-ready state

About you





- A background in science, engineering, biomedical, quality, or research
- Exceptional attention to detail and a low tolerance for loose ends or unresolved items
- Robust organisational and process-tracking skills, with the ability to manage a complex, deadline-driven workflow
- Able to read and follow technical and clinical documentation
- Clear written communication and confidence in following up with contributors for inputs
- Early-career candidates are encouraged to apply; prior regulatory experience is welcome but not essential

Desirable

- Familiarity with medical device quality systems or ISO 13485
- Exposure to international regulatory processes (e.g. TGA, FDA, CE/MDR)

What we offer

- Direct mentorship from experienced management and meaningful ownership within our regulatory function
- A clear progression path to Regulatory Affairs Specialist as the role develops
- Salary: $70,000–$90,000 + superannuation, commensurate with experience

How to apply

To apply, submit your CV with a cover letter that directly answers the question below. Applications without a cover letter addressing this question will not be considered.

This role is about keeping a complex, document-heavy process accurate and complete under deadline. Tell us why that kind of work suits you, and give one concrete example of detail-focused work you have done — what the task was, and how you made sure it was right.

Keep it short and specific — a few paragraphs is plenty.

📌 Regulatory Affairs Associate (Sydney)
🏢 Osseointegration International
📍 Sydney