I no longer am in regulatory affairs. I stopped working for a medical device company as their regulatory scientist in 2017. I liked the job at the beginning. It incorporated my skills in research and writing technical documents but after a while I became stressed by the responsibility of moving submissions through the FDA. I became aware that leading a project was going to be my be all and end all. If it ever went south, I would be held accountable for it. And I was. There was an instance when we went for a device that had three shapes to it. The FDA wanted one of the shapes removed or else it would not clear the submission and the device. We agreed, but the CEO of the company blamed me for this deleted shape’s demise. It wasn’t a good thing for me and it caused me my career there to go into a decline. It was not my fault. The shape they wanted caused problems in the clinic. It was all entirely the FDA’s purview to decide on the safety of a submitted device.

So I am now a full time writer, author, publisher and blogger. Looking for a job in regulatory has not been fruitful (I had some thoughts that wanted me to try for it again) and I began to think of how it might be like and then the recollection of what I went through in that place I worked at made me less eager to pursue looking for a regulatory job. Yes, the income would have been most welcome. They pay regulatory people well. But with that kind of income comes a great deal of responsibility, and stress and I wasn’t looking for that. I don’t want to say this but it’s true: with a big income you get to become a target for people if things don’t go right for whatever projects you are given. It’s not enough that the products are seemingly good. It’s what the company puts into these products in terms of their engineering and risk analyses. Knowing something more about these products over what they tell you what it does is something regulatory specialists have to do. If it’s something that’s not in your background (mine was in biology-chemistry) then it might be a lot of work to do research into the product. I cannot accept their word that this product works well enough to do it’s intended use. I have to do a lot of digging to see if their reports are true. Their QA needs to hold up and this is another thing that I have to deal with. It’s a lot of work. I’m not interested in doing all this – just writing the submission and submitting it to FDA is not enough. I just have a mind that’s now more creative and imaginative, not wanting to get into the prison of technical jargon and statistics.