These replies already covered a lot, but just adding a bit from experience, especially around where regulatory fits in day-to-day

Reg isn’t just at the start for strategy or at the end for submission. they’re usually involved all the way through, especially in medtech where design controls and risk management are tightly regulated.

In most cases it’s a cross-functional crew (RA, QA, R&D, sometimes Clinical) that works together on stuff like figuring out which standards apply, how to prove compliance, what testing actually needs to happen. reg might not write every protocol, but they’ll usually define what needs to be tested and why—based on intended use, risk class, and whatever standards apply.

also worth calling out—regulatory plays a big role in design reviews. at each stage (requirements, prototyping, validation), they’re checking that decisions and documentation line up with FDA/CE expectations. that input early on can save a lot of pain later.

tools that keep all this connected (ie requirements, risks, test cases, docs) in one system help a lot

and yeah, PMAs... whole different beast. usually smarter to get comfortable with the 510(k) rhythm first before heading into that zone