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Regulatory Affairs Specialist

2 months ago

Adelaide, South Australia AusBiotech Full time
Medical Devices Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs Specialist to join our Medical Devices Consulting team at AusBiotech. In this role, you will have the opportunity to work on various medical devices technologies, supporting a wide range of quality and regulatory activities.

Key Responsibilities:

  • Maximize client commercial success by ensuring appropriate licensing and regulatory compliance of client products.
  • Advise, support, and manage multiple quality and regulatory projects in parallel, liaising with clients, peers, and third-party subject matter experts.

Requirements:

  • Formal qualifications in science or engineering with 3 to 5 years' experience working in medical devices regulatory affairs, either in industry or a consulting setting.
  • Hands-on experience in preparing regulatory and technical submissions, preferably with the TGA, and a strong track record of success.
  • A can-do attitude, natural problem-solving skills, and strong focus on results.
  • Excellent interpersonal skills and ability to collaborate with colleagues and external stakeholders.

What We Offer:

  • A dynamic and globally renowned team of specialists in the medical devices regulatory affairs field.
  • A range of flexible working options, including part-time, varying start and finish times, and hybrid office/home working.
  • A diverse and inclusive work environment where all team members can thrive.