How do they match: Regulatory Affairs Specialists

  • Clinical Quality Assurance Associate
  • Clinical Quality Assurance Specialist
  • Risk and Compliance Analyst

  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Review clinical protocols to ensure collection of data needed for regulatory submissions.

  • Compile technical information or documentation.