I was going to write about China Labeling this week, but I didn't feel like it!
I would rather tell you about an interesting conversation that I had with my father-in-law. He was staying at my house for the week and heard me take several phone calls for work. When we sat down for breakfast, he asked me to explain exactly what I do in my job. I gave him the standard high level explanation: the medical industry is an industry that is regulated by the government and there are a set of “regulations” that medical device manufactures must follow in order to comply. I explained that I help Engineers and Designers make sure that they build product that adheres to the rules. Then the conversation went a little bit like this:
PAP: “So you are a lawyer?”
ME: “No, I am an Engineer.”
PAP: “But you don’t design the products like an engineer. You interpret the law for people that need to understand it. That is a lawyer.”
I have to admit that these words made me flinch. I have never thought of myself and my colleagues as “lawyers”. My brother is a lawyer and I worked in his office when I was going through school, so I have a pretty good idea what that entails. I have always thought that our jobs were at opposite ends of the spectrum.
I started thinking about the parallels between my brother’s job and mine. He uses the history of similar precedents in past court rulings to develop a plan to prove his legal case. I am currently writing a 510k where I am using the history of every past decision that the FDA has made on similar products to develop a plan to prove that our product is safe. He interprets the law and gives legal advice. I interpret the law and give legal advice. It really isn’t that different. (Except he makes about 50 times as much as I do!)
Pap’s simple statement really made me think. It was an interesting perspective.
So my question for you if you are a Regulatory Engineer: are you complimented, indifferent or offended by this analogy?