Medical Devices Regulatory Affairs Associate

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

Medical Devices Regulatory Affairs Associate

31 Jul 2024

Your Job

We have an opportunity for a Medical Devices Regulatory Affairs Associate to join our Medical Devices Consulting team based in Australia. In this role you will have the opportunity to work on many different medical devices technologies, supporting a wide range of quality and regulatory activities. Your primary objective is to maximise client commercial success by ensuring appropriate licensing and regulatory compliance of client’s products. In this role, you must be able to advise, support and manage multiple quality and regulatory projects in parallel, liaising with clients, peers and third party subject matter experts.

Your Profile

• You have formal qualifications in science, engineering with 3 to 5 years’ experience working in medical devices regulatory affairs either in industry or a consulting setting. Exposure to the full product lifecycle is a plus.
• You have hands‑on experience in the preparation of regulatory and technical submissions preferably with the TGA and a strong track record of success.
• You have a can‑do attitude, are a natural problem‑solver, a team player with strong focus on results. You have good attention to detail and at the same time, can keep a focus on the big picture and goals. You can prioritise and manage several projects at once.
• You have strong interpersonal skills and enjoy collaborating with colleagues and external stakeholders.

We offer

• By joining the PharmaLex Australia team you will become part of a team globally renowned as specialists in our field. Sharing knowledge and expertise with others is part of every day.
• We offer a range of flexible working options including part time, varying start and finish times and hybrid office/home working. We are a diverse workplace and we aim to create a work environment where all can thrive.
• Our head office is based in St Leonards, Sydney and whilst Sydney is our preferred candidate location we are open to considering candidates based in Brisbane, Adelaide, Canberra or Melbourne.