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Regulatory Affairs Specialist

2 months ago

Sydney, New South Wales, Australia ResMed Inc Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at ResMed Inc. As a key member of our Global Product Regulatory Affairs function, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.

Key Responsibilities
  • Develop and implement regulatory postmarket strategies to ensure compliance with FDA, TGA, and Notified Body regulations.
  • Represent Regulatory Affairs on cross-functional teams and collaborate with internal stakeholders to achieve business goals.
  • Analyze scientific content of submissions to ensure accuracy and sound presentation.
  • Monitor external standards and internal processes to ensure compliance.
  • Provide postmarket regulatory support and guidance as required.
Requirements
  • Minimum Engineering or Science Degree with six years of related experience in a medical manufacturer or equivalent combination of education and experience.
  • Knowledge of EU MDR regulations and ability to work independently with limited supervision.
  • Strong interpersonal communication skills and ability to prioritize workload.
  • Teamwork building skills and ability to exercise judgment.
About ResMed Inc

ResMed Inc is a leading medical device company that focuses on creating a diverse and inclusive culture. We encourage individual expression in the workplace and thrive on innovative ideas. If you are a motivated and detail-oriented individual who is passionate about regulatory affairs, we encourage you to apply for this exciting opportunity.