Competence matters!
As a matter of fact, there are certain roles for which there are pre-established background requirements.
Take for example the following paragraph from FDA's program 7382.845:
"However, if the firm's investigation does not change the alleged association between the device and the death, the event must be submitted as an MDR report. In addition, if the firm's investigation produces information that would cause a person who is qualified to make a medical judgment to reach a reasonable conclusion that the device did not cause or contribute to a reportable MDR event - no report is required. Translation - if a firm decides NOT to report an apparent device-related death, serious injury or malfunction - this decision must be made by a person that the regulation recognizes as qualified to make a medical judgment, i.e., a physician, nurse, risk manager, or biomedical engineer"