Regulatory Affairs Officer – Medical Devices

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

Benefits offered by this job

Free on‑site parking

Global RA & quality teams

Supportive, collaborative culture

Job summary

Pettit Pharma & Device Search – Sydney NSW is seeking a Regulatory Affairs Officer to support the preparation and submission of TGA regulatory applications for new products and changes. You will collate, review and maintain technical documentation to ensure regulatory compliance, develop regulatory strategies, and collaborate with global RA teams.

The role requires a Life Sciences degree, experience in regulatory affairs or medical device compliance, knowledge of the Australian framework, and

Qualifications

• 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.
• COVID-19 vaccination and full working rights in Australia.
• Willingness to work 5 days a week in Lane Cove West.

Responsibilities

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

Skills

Regulatory affairs knowledge

Attention to detail

Communication skills

Team collaboration

Education

Bachelor's degree in Life Sciences / Biomedical field

Job description

Pettit Pharma & Device Search – Sydney NSW is seeking a Regulatory Affairs Officer to support the preparation and submission of TGA regulatory applications for new products and changes. You will collate, review and maintain technical documentation to ensure regulatory compliance, develop regulatory strategies, and collaborate with global RA teams.

The role requires a Life Sciences degree, experience in regulatory affairs or medical device compliance, knowledge of the Australian framework, and