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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 Regulatory Affairs - Systems and Business Excellence Team member. The successful candidate will be responsible for ensuring the continuance of regulatory compliance of existing ResMed products, reviewing new and changing policies, regulations, and guidance documents, and maintaining and analyzing corporate and regulatory specific data.

Key Responsibilities
  • Manage the continuance of regulatory compliance of existing ResMed products.
  • Review new and changing policies, regulations, and guidance documents issued by global regulatory agencies.
  • Maintenance and analysis of corporate and regulatory specific data.
  • Initiate, support, and coordinate process improvement projects related to operational processes, digital tools, and databases.
  • Assist with regulatory submissions, regulatory license applications, and technical documentation audits.
  • Represent Regulatory Affairs on cross-functional business projects.
  • Support the Regulatory Affairs team in project tasks as they arise.
  • Work within the ResMed Quality system.
Requirements
  • Excellent attention to detail, strong organizational and communication skills.
  • Ability to work within a team and also independently.
  • Ability to prioritize, coordinate multiple projects simultaneously, and work to timelines.
  • Agility and flexibility.
  • Strong understanding of global regulatory requirements and submission processes.
Qualifications and Experience
  • Bachelor's degree in Engineering, Computer Science, Life Sciences, Regulatory Affairs, or a related field.
  • Minimum of 3-5 years of experience in regulatory affairs within the medical device industry.
  • Familiarity with ISO 13485, ISO 14971, FDA 21 CFR Part 820, and other relevant standards and regulations.