Medical Devices Regulatory Affairs Specialist (Hybrid)

AusBiotech; Adelaide; Hybrid; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Flexible working options

Hybrid office/home working

Global team collaboration

Job summary

PharmaLex Australia seeks a Medical Devices Regulatory Affairs Associate to join our consulting team in Australia. You will drive licensing and regulatory compliance across diverse medical devices and support a broad range of quality activities.

You will advise, support and manage multiple projects, liaising with clients, peers and external subject matter experts to maximise client outcomes. Flexible/hybrid options available.

Qualifications

• Formal qualifications in science or engineering.
• 3–5 years in medical devices regulatory affairs.
• Experience with regulatory submissions, ideally TGA.

Responsibilities

• Advise and manage multiple quality and regulatory projects in parallel.
• Prepare regulatory and technical submissions with focus on compliance.
• Liaise with clients, colleagues and external subject matter experts.

Skills

Regulatory affairs

Project management

Stakeholder collaboration

Attention to detail

Multi-project prioritisation

Education

Science or engineering degree

Job description

PharmaLex Australia seeks a Medical Devices Regulatory Affairs Associate to join our consulting team in Australia. You will drive licensing and regulatory compliance across diverse medical devices and support a broad range of quality activities.

You will advise, support and manage multiple projects, liaising with clients, peers and external subject matter experts to maximise client outcomes. Flexible/hybrid options available.