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
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