- 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.
Additional information
- Based 5 days a week in Lane Cove West with free on-site parking
- Work with global RA & quality teams
- Join a leading global medtech company with exceptional support
#J-18808-Ljbffr
📌 Regulatory Affairs Officer - Medical Devices (New South Wales)
🏢 Pettit Pharma & Device Search
📍 New South Wales
Reply to this offer
Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.