How do they match: Regulatory Affairs Specialists

  • Quality Assurance Documentation Coordinator
  • Quality Assurance Documentation Specialist

  • Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.

  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
  • Compile and maintain regulatory documentation databases or systems.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • 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.
  • Identify relevant guidance documents, international standards, or consensus standards.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.

  • Prepare financial documents.
  • Prepare regulatory or compliance documentation.
  • Compile technical information or documentation.
  • Coordinate regulatory documentation activities.
  • Obtain documentation to authorize activities.
  • Review documents or materials for compliance with policies or regulations.