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Regulatory Affairs Specialist

2 months ago

The Hills Shire Council, 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 Global Regulatory Compliance Expert. The successful candidate will be responsible for ensuring the company's products comply with regulatory requirements and will work closely with internal stakeholders and external regulators to achieve business goals.

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.
  • Coordinate 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
  • 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.
What We Offer

We are committed to creating a diverse and inclusive culture that encourages individual expression and innovation. As a Regulatory Affairs Specialist at ResMed Inc., you will have the opportunity to work with a talented team and contribute to the development of life-changing products that improve the lives of people with sleep apnea, COPD, and other respiratory conditions.