Position Title: Regulatory Affairs Assistant

Location: 17171 Murphy Ave, Irvine CA 92614

Reports to: QA and Regulatory Affairs Officer

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Summary/Contribution of Position:

The purpose of this position is to support duties and functions related to Regulatory Affairs.

Essential Duties and Responsibilities:
  • Assist Regulatory Affairs (R.A.) with company registrations and device listings in domestic (U.S.) and international markets
  • Assist R.A. with technical files for IVDD/IVDR certifications/registrations
  • Assist R.A. with preparing and submitting product registrations and submissions (510(k)) to FDA and other regulatory bodies
  • Assist with reviewing and writing standard operating procedures and other RA policies as necessary
  • Collaborate with technical staff to foster understanding of SOPs and guidance documentation
  • Coordinate with cross functional teams regarding product change, regulatory notification and/or approval requirements
  • Assist with analyzing marketing ads, labels, and public communication documents for regulatory compliance
  • Assist with evaluating product compliance to applicable regulations and project requirements
  • Participate and assist with inspections, notified body audits, and other government inspections as needed
  • Perform other related duties and projects as business needs require at the direction of management
Education and Experience:
  • Bachelor's degree in a science discipline preferred
Knowledge and Abilities:
  • Strong interest in Regulatory Affairs, regulations, guidances required
  • Proficient skills in the MS Office Suite (Excel, Word, PowerPoint, and Outlook)
  • Ability to analyze and collate data for presentations and reports
  • Highly organized and efficient worker with excellent time management skills and attention to detail
  • Ability to multi-task and prioritize appropriately
  • Willingness to take initiative and work independently when needed
  • Demonstrated professional integrity with confidential information
  • Willingness to learn new things
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