We have been working software for FDA submissions as well. We use Jama https://www.jamasoftware.com/ for requirements management and traceability to test cases.
I have also used Jama in a couple of companies. One for medical devices and one doing avionics.
My experience is that it's quite similar to Jira in that if it's set up well it can work really well. If it's set up poorly it is a massive pain.