- 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.
- 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.
- As the Regulatory Affairs Officer you will be responsible for supporting the preparation and submission of TGA regulatory applications for new 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.
- 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.