My previous employer sells blood typing kits to many countries around the world and we are regulated by several bodies around the world. While most of their focus overlaps other things like labeling requirements have small differences which could mean the difference between being able to push your product into market in a certain country or not.

Each jurisdiction has its own requirements and one of the simplest yet easiest thing get caught on are the labels. For each region we had different labels due to different symbol requirements. Even though the product is exactly the same from documentation to testing to processes, everything 100% the same, the final package labels were different so they had completely different part numbers and could not be shipped to all customers. Some of these things (packaging, labeling, IFUs) that we, the consumers, don't pay too much attention to become the reason why a perfectly good product goes off the market.

I think it's also good to mention that this is one of the areas where a PM comes in. While developing product, it is easy to overlook these seemingly small things. The PM brings all departments to the table to ensure things like this don't get overlooked and all technical and regulatory requirements are met.

I have not worked on a regulatory project, however I have worked with regulatory. I figured I would share to give a perspective of some things Regulatory people do. I work often on non conformances within the company. These are deviations from current processes the company needs to follow. Sometimes these non conformances can have a regulatory impact because a mistake was made that would cause us not to meet regulatory guidelines. For example, a non conformance could be that the label on a product is inaccurate. So we consult Regulatory on the risk that would have and if re-labeling is an option. Additionally, we have certain products that are distributed in Australia, which is more stringently regulated. Regulatory is often consulted to ensure that our processes meet their criteria. They are heavily involved in new product development as well. 

Although I have not worked on a regulatory project, I have worked with regulatory authorities. I figured I'd share to give you an idea of what regulatory professionals do. Within the company, I frequently work on non-conformances. These are variations from the company's present practices that must be followed. Because a mistake was made that caused us to fail to follow regulatory requirements, these non-conformances might sometimes have a regulatory consequence. For example, a non-conformance may be that a product's label is incorrect. As a result, we speak with Regulatory to determine the risk and whether re-labeling is an option. In addition, some of our items are distributed in Australia, where regulations are more severe. Regulatory is frequently contacted to verify that our procedures comply with their requirements. They are also significantly involved in the creation of new products.

I have not worked in a regulatory project but I have worked in government inspections and enforcement.  My first experience in the field was in zoning code enforcement.  I was responsible for enforcing the Denver Zoning Code and portions of the Denver Revised Municipal Code.  It required extensive studying of the code, grandfather situations, and CYA in all enforcement action.  Those documents were legally binding and under scrutiny in court, appeals hearings, and adjustment requests.  I also spent time time in Public Health Inspections where I was responsible for inspecting to ensure of the safe operation of restaurants in Denver.  That required an understanding of FDA food regulations and enforcing the Denver Food Code which mirrored most FDA regulations.  There was also experience with the Colorado Department of Labor where I worked in unemployment claims and later collections.  That required the ability to adapt to quickly changing legislation which is common place when talking about unemployment, especially during recession and economic downturn.  

I have worked on a few different projects that I have worked with my regulatory counterpart to aid with submissions. This one project had myself and my coworked work with ANVISA to have a product already approved in the US to be released in Brazil. We needed to test the implants through a similar rigor as verification since a no-test rationale was used in lieu of verification testing since the system was a cannulated version of a previous released product. Brazil didn't accept the no-test rationale and that was the reason why we had to have the parts tested to prove to them that they are as strong as our company claims they are. It was an interesting situation as there were a few questions ANVISA had on the report I had drafted for the test results on equivalency to the predicate and there were multiple times after the project ended that my coworker and I had found we were sent an email with an additional questions or comment from our ANVISA partners. Overall, the project was a success. One thing to note is to ask regulatory on which regulations they have and what similarities there are to the FDA's regulations to see what may be needed additionally. 

In the past have worked with regulatory for various projects, however when I worked on the EU MDR project had a first hand experience working with them. It was very chaotic at that time as EU MDR regulations were not well defined, therefore all decision were based on risks. What impact would decision have on the business and how long would it take to revert if it was a "mistake". Regulatory is also frequently asked to verify that the company procedures comply with federal requirements.