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

Regulatory Affairs Officer - Medical Devices

Pettit Pharma & Device Search – Sydney NSW

6d ago , from Pettit Pharma & Device Search

• 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 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.

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