How do they match: Regulatory Affairs Specialists

  • Risk and Compliance Analyst

  • 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.

  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Develop or conduct employee regulatory training.
  • Develop or track quality metrics.
  • 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.
  • Identify relevant guidance documents, international standards, or consensus standards.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Monitor national or international legislation on ozone-depleting substances or global warming.
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
  • Participate in internal or external audits.

  • Communicate with government agencies.