How do they match: Regulatory Affairs Specialists

  • Regulatory Submissions Associate

  • 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.

  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • Monitor national or international legislation on ozone-depleting substances or global warming.
  • 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.