Regulatory Affairs Associate

About Us

Osseointegration International Pty Ltd is a Sydney-based medical device company specializing in the design and manufacture of osseointegration implant systems for amputee patients. Our products are distributed globally across numerous international markets.

Role Overview

We are looking to appoint a Regulatory Affairs Associate to strengthen our regulatory affairs operations. This role centers on managing processes to ensure accuracy and timeliness in regulatory submissions. Extensive prior regulatory experience is not necessary as training on existing procedures will be provided. The ideal candidate will demonstrate exceptional attention to detail and strong organizational skills, eager to build a career in medical device regulatory affairs.

Responsibilities

• Maintain logs and trackers for regulatory submissions and correspondence
• Handle document control duties including version tracking and approval management
• Prepare and format regulatory documents according to specified standards
• Conduct cross-referencing of claims, evidential documents, and test reports to guarantee consistency and traceability
• Coordinate contributions from internal teams and external consultants and proactively follow up on pending items
• Assist in preparing and monitoring responses to regulatory inquiries
• Ensure that technical documentation remains inspection-ready at all times

Candidate Profile

• Educational or professional background in science, engineering, biomedical fields, quality assurance, or research
• Meticulous attention to detail with an intolerance for incomplete or unresolved items
• Excellent organizational skills capable of handling complex workflows and meeting deadlines
• Ability to comprehend and interpret technical and clinical documents accurately
• Strong written communication skills and confidence in liaising with contributors to obtain necessary inputs
• Applicants early in their career are encouraged; previous regulatory experience is advantageous but not required

Desirable Attributes

• Knowledge of medical device quality systems or ISO 13485 standards
• Exposure to international regulatory bodies and regulations such as TGA, FDA, or CE/MDR

Benefits

• Direct mentoring from experienced management
• Significant responsibility and ownership within the regulatory function
• Structured progression path toward the Regulatory Affairs Specialist position
• Competitive salary ranging from $70,000 to $90,000 plus superannuation, adjusted based on experience

Application Instructions

Candidates must submit a CV alongside a focused cover letter addressing why meticulous, deadline-driven regulatory work is suitable for them and detail one specific example demonstrating their accuracy and attention to detail in previous tasks. Applications not containing this cover letter will not be considered.