Regulatory Affairs Officer

PPD Search; Sydney; On-site; AUD 90,000 - 120,000; Full time

Job summary

PPD Search is seeking a Regulatory Affairs Officer in Sydney to support regulatory submissions for medical devices across Australia. The role involves preparing technical documentation, ensuring compliance with TGA requirements, and aligning with global regulatory teams.

The successful candidate will have a life sciences or engineering degree and proven experience in regulatory affairs and quality systems within the medtech sector, with strong communication and detail-oriented skills.

Qualifications

• Bachelor’s or higher 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.

Responsibilities

• Support preparation and submission of TGA regulatory applications for new products and changes.
• Collate, review and maintain technical documentation for regulatory compliance.
• Assist in developing regulatory strategies and submission plans with timelines.
• Collaborate with global Regulatory Affairs teams to align documentation and standards.
• Review product labelling, marketing materials and technical files for regulatory accuracy.
• Provide regulatory guidance to internal teams including Product and Commercial.
• Support QMS activities, updates to SOPs and audit readiness.
• Monitor changes in regulatory requirements and share updates with stakeholders.

Skills

Regulatory affairs

Quality

Medical device compliance

TGA regulations

Education

Life Sciences or Biomedical Engineering degree

Job description

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.
• 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.