MedTech Regulatory Affairs Officer – TGA & QMS Expert

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

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.