Senior Specialist, Regulatory Affairs-Medical Devices Expert

5 days ago


Sydney, New South Wales, Australia Pharmalex Full time

About Us

Pharmalex is a leading service company for the Pharmaceutical Industry globally, specializing in all aspects of drugs and medical devices approval, market development, and product maintenance.

Job Summary

We are seeking a Medical Devices Regulatory Affairs Associate to join our Medical Devices Consulting team in Australia. As a Senior Specialist, Medical Devices, you will work on various medical devices technologies, supporting quality and regulatory activities. Your primary objective is to ensure licensing and regulatory compliance of client products, advising and managing multiple quality and regulatory projects.

Key Responsibilities

  • Prepare regulatory and technical submissions for the TGA and other regulatory bodies.
  • Collaborate with clients, peers, and subject matter experts to ensure compliance and success.
  • Manage multiple projects simultaneously, prioritizing tasks and meeting deadlines.
  • Develop and maintain strong relationships with clients and stakeholders.

Requirements

  • Formal qualifications in science or engineering with 3-5 years of experience in medical devices regulatory affairs.
  • Hands-on experience in regulatory submissions and a strong track record of success.
  • Excellent problem-solving skills, attention to detail, and ability to prioritize tasks.
  • Strong interpersonal skills and ability to collaborate with colleagues and external stakeholders.

What We Offer

  • A globally renowned team of specialists in our field, sharing knowledge and expertise.
  • A range of flexible working options, including part-time, varying start and finish times, and remote working.
  • A diverse workplace where all can thrive, with opportunities for growth and development.


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