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Regulatory Affairs Specialist

2 months ago

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

The Regulatory Affairs Specialist will lead regulatory affairs strategy to be aligned with objectives of our post market products. This role will be responsible for planning and coordinating regulatory post market strategies, representing Regulatory Affairs on selected post market cross-functional teams, and developing and implementing submissions to regulatory authorities.

Key Responsibilities
  • Plan and coordinate regulatory post market strategies
  • Represent Regulatory Affairs on selected post market cross-functional teams
  • Develop and implement submissions to regulatory authorities
  • Analyze the scientific content of submissions to ensure they are accurate and soundly presented
  • Monitor the status of submissions and advise stakeholders of their progress
  • Monitor external standards and internal standards
  • Maintain an up-to-date knowledge on all regulatory matters and advise senior management of potentially significant changes to post market strategies
  • Manage the continuance of regulatory compliance of existing ResMed products in selected region(s)
  • Ensure clinical trials are conducted in accordance with the best opportunity to achieve regulatory approval
  • Provide post market regulatory support and guidance as required
  • Manage special projects as required
Job Environment

ResMed's products must comply with the regulatory requirements applicable to medical devices for the markets in which they are sold. This includes, but is not limited to, the Food and Drug Administration (FDA) in the United States of America, the relevant competent authorities in Europe and the Therapeutic Goods Administration (TGA) in Australia, as well as applicable international standards such as ISO 13485.

Qualifications and Experience
  • Minimum Engineering or Science Degree
  • Six (6) related experience with a medical manufacturer or equivalent combination of education and experience
  • Knowledge of EU MDR regulations
  • Must be detail oriented & highly organized
  • Ability to work independently and exercise judgment with limited supervision
  • Must possess strong interpersonal communication skills
  • Ability to prioritize workload with limited supervision
  • Must demonstrate teamwork building skills in & outside department
  • Ability to exercise judgment