How do they match: Regulatory Affairs Specialists

  • 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 pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.