How do they match: Regulatory Affairs Specialists

  • Clinical Quality Assurance Associate
  • Clinical Quality Assurance Specialist

  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
  • 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.
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.