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Regulatory Affairs Specialist

2 months ago

Sydney, New South Wales, Australia ResMed Inc Full time

Job Summary:

The Regulatory Affairs Coordinator supports the regulatory affairs team in ensuring compliance with local, regional, and international regulations for medical devices.

Key Responsibilities:

  • Regulatory Submissions: Assist in the preparation of regulatory documentation for product registrations, amendments, and renewals in compliance with global regulatory requirements.
  • Document Management: Maintain up-to-date regulatory documents and ensure proper organization, tracking, and archival of submission dossiers, technical files, and other regulatory records.
  • Communication & Coordination: Collaborate within the RA departments to gather necessary information for regulatory submissions and maintain clear communication with regulatory agencies.
  • Post Market Surveillance Support: Assist in coordinating post market activities such as adverse event reporting, field actions, and periodic safety updates in accordance with applicable regulations.
  • Regulatory Database Management: Update and maintain databases related to regulatory submissions, approvals, and compliance tracking.
  • Audits & Inspections: Provide support during regulatory audits and inspections, helping to prepare and organize necessary documents and reports.
  • Training & Documentation: Assist in developing and updating training materials on regulatory processes, ensuring company-wide awareness of compliance obligations.

Requirements:

  • Bachelor's degree in Life Sciences, Regulatory Affairs, or a related field.
  • 1-3 years of experience in regulatory affairs, preferably within the medical device, pharmaceutical, or biotech industries.
  • Familiarity with global regulatory requirements (e.g., FDA, EMA, Health Canada, TGA, etc.).
  • Proficient in regulatory submission processes, document management systems, and quality systems.
  • Strong organizational skills and attention to detail.
  • Excellent verbal and written communication skills.
  • Ability to work both independently and collaboratively in a fast-paced environment.
  • Proficiency in Microsoft Office (Word, Excel, Power Point).