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Switching to a Regulatory Career

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(@cn249)
Posts: 12
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I would like to say that I am in the beginning phase of my career. I do not think I would switch from the engineering role to the regulatory role. Honestly I have not considered a more regulatory role in the industry, but I can greatly see the benefits of working in the regulatory department. The regulatory department can be seen as the middle ground between the legal and medical aspects for certain devices or drugs. Their roles can have an impact on the world with the different developments of medical devices and drugs since this is promoting health and safety. Their roles include working with the project team, management, and the FDA. The main job of regulatory is to understand the regulations and guidelines set by the FDA for devices and drugs, as well as the devices and drugs about to be put on the market.This is where the lesson mentioned that the regulatory department research and meet with the project team to learn about the product they want to develop and put on the market. Then, they keep in touch with the FDA while writing documents to provide guidance to the project team on regulations and making sure it adheres to the FDA guidelines. 
One thing I noticed with this role is that it is not just focused on one field or aspect. There is a combination of science, business, law, tech, and medicine. People that work in the regulatory department tend to build and learn new skills such as problem solving, collaboration, communication, and organization. I think that these types of positions provide you an all-rounder experience for possible future positions and other opportunities. There are a lot of opportunities for growth from working in the regulatory department, especially for those that do not have much industry experience overall. Unless you really enjoy the regulatory role, then you have a job set for life. It seems to be a viable career path as you are constantly learning and building your skills. You are there from the beginning of the project towards the end of it, and even beyond with your guidance and maintenance.  It can feel rewarding since you are potentially steering your company towards a direction for great success with keeping documentation, reports, and procedure in check with the FDA, the product, and the consumers. As the original post said, the paperwork and documentation does not seem too appealing as it can also be stressful at times since you have to write documents with precise data presentation and formats like the PMA or 510(K) that follows the FDA guidelines.


 
Posted : 24/09/2025 4:17 pm
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