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Just need to vent off a little steam... 1

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Norse1957

Mechanical
Jul 12, 2018
6
Hi all,

Not sure how many of you do engineering work where you have to deal a lot with Regulatory Affairs "Specialists", but if you're in the medical device industry or a highly regulated industry I'm sure you have. Especially if you're in production and making sure you stay off the FDA's watch list. What I don't understand is why more companies don't require their RA folks to be fairly well versed in engineering. There's been times in my past where I've worked with RA depts. that had at least one of RA specialist who was well versed in engineering... Sure made things move quicker & easier. Where I'm at now, there's nobody. So, not only do I find myself having to explain basic things like my reason for adding an h9 shaft fit or a 6g thread callout, but I also will explain things, and then they go and write their RA assessment all wrong, where I realize they completely misunderstood what I told them. Is it that rare to find an RA specialist with a decent grasp of engineering? How do you all deal with this frustration? It wasn't too much of an issue when everything was at an R&D phase, but now being in production, this process of getting drawing changes and other documentation approved in a timely manner is next to impossible.

Thanks for letting me vent!

Jack
 
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Unless you have the means to alter the hiring policy of your company, you won't change who the RA's are.
If you can't avoid this in some way, and you have to interact with them often, try cultivating a radio/television host style and level of detail. When you talk to them, describe things in terms they already understand.

In their world...
There are no pressure vessels with a thousand gallon capacity,
but there are olympic-sized swimming pools​
There are no precipitation boundaries between crystal grains in oil-quenched alloys,
but there are cherries in a fruitcake​
There are no precision ground and lapped bearing surfaces,
but there are kitchen tables waxed and polished until you see your reflection​

I think you get the idea.
 
Caution should be exercised with the use of highly simplified analogies as many/most RA (Regulatory Affairs) specialists are life sciences/medical graduates and there is a risk of alienation of trust if the use of analogies is misinterpreted as a dumbing-down of information. Yes, the overhead imposed by medical product development can be a challenge. I have found providing more information upfront as part of the change/design analysis (than normally provided to a straight engineering audience) can often reduce the secondary questions. I have found my level of frustration is reduced when I expect requests for additional clarification than if I expect the RA reviewer will see the obvious reasons for actions/change and not ask for more guidance.
 
My employers have only allowed the most senior engineers in RA roles bc of the breadth of engineering, product history, and regulatory knowledge needed to defend new products and provide feedback on proposed legislation to regulators.

I'd bring your concern to management bc if internal communication with RAs is lousy then its worse externally and may cause regulatory issues and loss of business.
 
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