When most people think about Regulatory Affairs they think CE marking, Shonin, 510(k) clearance. And yes, we do all of this! To be very succeful in submissions the prework is important, We typical do a gap analyse to ensure that all documentation exist before making the submission. Getting on hold or RTA letter from FDA will delay the process and you might loose important time in gaining market access!
We do submissions all the time and hence know current best practice!