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 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.

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.

Solid 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.

Interested? Please 'apply now' quoting reference number 3883 or call Nicole Villanueva, on 0414 919 461. Please note, your details/resume will not be sent anywhere without a formal interview and, if successful, your subsequent prior permission. Personal information provided will be used for recruitment purposes only and be treated in the strictest confidence. Only shortlisted candidates will be contacted.

📌 Regulatory Affairs Officer (Lane Cove West)
🏢 PPD Search
📍 Lane Cove West