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Medical Device Regulatory Affairs Manager

1 week ago

Sydney, New South Wales, Australia Dexcom Inc. Full time

About Dexcom Inc.

Dexcom Inc. is a pioneering company in the field of Continuous Glucose Monitoring (CGM) technology, working tirelessly to improve the lives of patients with diabetes.

We partner with leading innovators to introduce cutting-edge solutions in healthcare and science, ultimately benefiting both patients and healthcare providers.

As a key player in the Medical Devices Industry, you will encounter a diverse array of products that significantly enhance the quality of life for patients.

Meet the Team:

The Regulatory Affairs department comprises over 40 experts stationed at our San Diego HQ or working remotely globally. This talented group brings together individuals with expertise spanning biology, physics, engineering, politics, statistics, pharmacology, and law.

Our team members hold various degrees, including Bachelor's, Master's, Ph.D.'s, and JD's. United by their diverse backgrounds and skills, they facilitate seamless collaboration across departments to deliver high-quality products to our customers.

Job Summary:

  • You will work closely with regional regulatory representatives to develop tailored regulatory strategies and prepare submission documents for Australia and other APAC countries.
  • You will oversee the creation, review, and approval of product labels, IFUs, and packaging for the APAC market.
  • You will serve as a Regulatory Affairs representative on cross-functional teams, offering strategic guidance and technical expertise on regulatory matters in the APAC region.
  • You will evaluate advertising materials to ensure compliance with local regulations.
  • You will assess the regulatory implications of proposed product changes and implement necessary actions.
  • You will stay updated on evolving regulations in APAC countries and their impact on existing registrations and procedures.
  • Provide regulatory support during internal and external audits.
  • You will handle additional tasks as assigned.

Key Skills:

  • A thorough understanding of regulatory frameworks in Australia, New Zealand, and internationally.
  • Excellent technical writing, editing, and analytical skills.
  • An ability to work effectively as an individual and as part of a collaborative team.
  • Strong problem-solving, learning, organizational, and communication skills.
  • Prior experience with regulatory submissions in Australia and New Zealand is highly valued.