Regulatory Affairs Officer - Medical Devices
Global, well established medical device company renowned for their surgical product innovation.
They specialise in developing bespoke surgical solutions which make a difference and are known for their high quality and reliability.
Very values driven organisation with an exceptionally supportive, hands on and collaborative team.
THE COMPANY YOU WOULD BE JOINING
Global, well established medical device company renowned for their surgical product innovation.
They specialise in developing bespoke surgical solutions which make a difference and are known for their high quality and reliability.
Very values driven organisation with an exceptionally supportive, hands on and collaborative team.
WHAT'S IN IT FOR YOU
Global, family-owned medtech company with a 120+ year legacy delivering cutting-edge surgical instruments, implants and operating-theatre solutions worldwide.
Small, close knit team in an established company whose culture is very collaborative.
A company that invests heavily in their people.
THE JOB RESPONSIBILITIES
As the Regulatory Affairs Officer you will be responsible for supporting the preparation and submission of TGA regulatory applications for current products and changes.
Collate, review,



and maintain technical documentation to ensure compliance with regulatory requirements.
Assist in developing regulatory strategies, submission plans, and managing timelines.
Collaborate with global Regulatory Affairs teams to align on documentation and compliance standards.
Review product labelling, marketing materials, and technical files for regulatory accuracy.
Provide regulatory guidance and support to internal teams including Product and Commercial.
Support Quality Management System (QMS) activities, including SOP updates and audit readiness.
Monitor and interpret changes in regulatory requirements, sharing updates with key stakeholders.
WHAT YOU WILL NEED TO GET THE JOB
Degree in Life Sciences, Biomedical Engineering, or related field.
Experience in Regulatory Affairs, Quality, or Medical Device Compliance.
Knowledge of TGA regulations and Australian regulatory framework.
Strong attention to detail, organisation, and communication skills.
You must be vaccinated against COVID-19 and have full working rights for Australia.
Must be able to work 5 days a week in Lane Cove West.
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📌 Regulatory Affairs Officer - Medical Devices (Sydney)
🏢 PPD Search
📍 Sydney