This past summer I managed a co-op and with the fluctuation in covid transmissibility the company restrictions were constantly changing too. I had to be flexible enough to change the timeline of her co-op to ensure she would receive the…   Read more»

This actually was a very interesting topic as I can see both sides of the argument and support parts of them equally. I  understand all processed products will have a degree of undesirable components and that the FDA sets standards…   Read more»

As mentioned by many individuals in this thread, soft skills and the ability to effectively communicate are critical to any team based role especially one where you are the one leading the efforts. While I would agree that is one…   Read more»

This is a great question! I think I would prefer to be working in the product development side of the regulatory department, because I love the design process. Playing a part in the design of a product that will, hopefully,…   Read more»

I think one of the most important skills is good communication skills. As we learned from our first lecture, success equals 70% interpersonal skills plus 30% technical knowledge. Interpersonal skills are the key to personal success and also to project…   Read more»

There are many advantages to grouping projects under a program. First, it will improve the efficiency of the whole team by resource allocation. A program might have several projects and the project manager could assign the best available resource to…   Read more»

In my opinion, emotions are tied to personality, so each individual displays different emotions under different circumstances. Likewise, individuals handle stress and conflicts differently. In the role of a PM for example, emotions of others need to be handled properly,…   Read more»

Grouping projects under a program is important for the longevity of the program. When relating the projects into one area of interest (device type, target market, etc.) it allows the program to reflect the emergence of the ideas and progress…   Read more»

In my opinion, the overall responsibility of the FDA to ensure all drug/food/medical devices meet current regulatory and safety requirements is a super important one. Without the FDA, we cannot guarantee that some of the medicines or food we buy…   Read more»

It is tricky to resolve conflict within a team as a Project Manager. I feel as though it’s difficult to take “sides” in a conflict as you may be causing an even greater rift in the team which will not…   Read more»

Thank you for good information. However, I do not yet understand exactly the relationship between the regulatory professionals and project management. Should the person who works project management, such as a project manager, be well aware of the regulatory rules?…   Read more»

I think it is difficult to conclude which department is more important because both departments are important. I would like to work in post-market management. I have heard from developers before that very few products continue to survive on the…   Read more»

Although @devdesai raises some good points, from an ethical perspective, I have to disagree. Yes, the presence of antifreeze constitutes as ways of preservation but how ethical is it? There are quite a few ingredients that the FDA approves of…   Read more»

Great question! As discussed, the role of the regulatory department includes product development and post-market management which require some background of project management. Project management is crucial for those with regulatory roles. There are many different subcategories within the umbrellas…   Read more»