My company is looking to build a regulatory affairs function - potentially under legal. Does anyone have examples of how regulatory affairs programs are structured within your company? Not looking for confidential information. Just looking to know where the function sits, how many employees/structure vs. company size, what types of roles (attorneys, specialists, other professionals?)

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Additional Posts in Regulatory Affairs

Hi there - early in my career. Just under two years in this role… is anyone in a regulatory role fully or 60% in person? Regulatory from what I’ve experienced is a pretty independent role. Does it get better as you move up in roles or is it pretty solo work. Your insight is welcome :)

Hi everyone! I’ve created this bowl as I haven’t seen any regulatory affairs specific bowls so I’m hoping we can all connect here.

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Hello! With rising inflation costs I’ve been casually browsing RA openings at other companies, wondering if I could negotiate a substantial pay increase. There don’t seem to be many regulatory roles open, would the roles be called something else in other orgs? For reference, I’m a consultant with 5 yoe in RA roles and 8 yoe in healthcare generally.

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How much is a good salary for regulatory affairs specialist?

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Hi everyone! I’m currently in RA (MedTech), considering going to law school. Is there a current/future need for regulatory affairs attorneys in the industry? It’s a very specific niche within MedTech. I’m a bit hesitant to invest time + money in law school just to end up writing 510(k)s like I am now without a JD.

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