Job Description
Regulatory Affairs Officer - Medical Devices
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Pettit Pharma & Device Search – Sydney NSW
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2d ago , from Pettit Pharma & Device Search
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Global, well established medical device company renowned for their surgical product innovation.
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They specialise in developing bespoke surgical solutions which make a difference and are known for their high quality and reliability.
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Very values driven organisation with an exceptionally supportive, hands on and collaborative team.
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THE COMPANY YOU WOULD BE JOINING
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Global, well established medical device company renowned for their surgical product innovation.
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They specialise in developing bespoke surgical solutions which make a difference and are known for their high quality and reliability.
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Very values driven organisation with an exceptionally supportive, hands on and collaborative team.
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WHAT'S IN IT FOR YOU
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Global, family-owned medtech company with a 120+ year legacy delivering cutting-edge surgical instruments, implants and operating-theatre solutions worldwide.
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Small, close knit team in an established company whose culture is very cooperative.
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A company that invests heavily in their people.
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THE JOB RESPONSIBILITIES
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As the Regulatory Affairs Officer you will be responsible for supporting the preparation and submission of TGA regulatory applications for new products and changes.
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Collate, review,



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