Regulatory Affairs Specialist

18 hours ago


Sydney, New South Wales, Australia Pharmalex Full time

Unlock Your Career Potential

We are a dynamic company with a passion for innovation and growth. If you are looking for a challenging role that will help you develop your skills and expertise, we have an exciting opportunity for you.

About the Role

We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our Medical Devices Consulting team in Australia. As a key member of our team, you will be responsible for ensuring the regulatory compliance of our clients' products and providing expert advice on quality and regulatory matters.

Your Key Responsibilities

  • Prepare and submit regulatory and technical documents to regulatory authorities, such as the TGA.
  • Develop and implement quality and regulatory strategies to ensure compliance with relevant regulations.
  • Collaborate with clients, peers, and subject matter experts to deliver high-quality projects.
  • Provide expert advice on regulatory and quality matters to clients and internal stakeholders.

Your Profile

  • You have a degree in science or engineering and 3-5 years of experience in medical devices regulatory affairs.
  • You have hands-on experience in preparing regulatory and technical submissions and a strong track record of success.
  • You are a natural problem-solver, a team player with a strong focus on results, and excellent interpersonal skills.

What We Offer

  • A dynamic and supportive work environment with opportunities for growth and development.
  • A range of flexible working options, including part-time and remote working.
  • The chance to work with a globally renowned company and contribute to the success of our clients.


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