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 Specialist, Regulatory Postmarket Compliance. This role will be responsible for leading regulatory affairs strategy to ensure compliance with postmarket regulations and quality standards.

Key Responsibilities
  • Develop and implement regulatory postmarket strategies to ensure compliance with FDA, TGA, and international regulations.
  • Represent Regulatory Affairs on cross-functional teams to drive global collaboration and achieve company objectives.
  • Analyze scientific content of submissions to ensure accuracy and sound presentation.
  • Monitor external and internal standards to ensure compliance and identify areas for improvement.
  • Manage special projects and provide postmarket regulatory support as required.
Requirements
  • Engineering or Science Degree
  • At least 6 years of experience in regulatory affairs with a medical manufacturer or equivalent combination of education and experience.
Preferred Qualifications
  • Knowledge of EU MDR regulations
  • Detail-oriented and highly organized with strong interpersonal communication skills.
  • Ability to work independently and exercise judgment with limited supervision.
About ResMed Inc.

ResMed Inc. is a global leader in the development, manufacturing, and marketing of medical devices for the diagnosis, treatment, and management of sleep-related breathing disorders, as well as other respiratory diseases. We are committed to creating a diverse and inclusive culture that encourages individual expression and innovation.

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