While I have not switched from a more traditional engineering role to a regulatory role, I have interacted heavily with regulatory partners and I believe that there is great benefit to gaining regulatory experience. Most specifically, regulatory in a global medical device company requires knowledge of global regulatory bodies and an understanding of the cultural nuances associated with interacting with these global regulatory bodies. While there is a lot of paperwork involved, there is also a lot of communication and social skill needed, as well as technical knowledge of the medical devices that you are submitting for review. Regulatory is a key partner for design reviews and determine how a device design will pass through. So the experience in regulatory will provide a global perspective on the devices, greater product knowledge and involvement, and improved communication skills!

While I have not considered a move to regulatory, I have seen a fair amount of my colleagues do so with much success.  Being that I have a Chemistry background working in biotech/pharma, generally, a BS degree in any science should suffice for a role in regulatory.  Experience, however, in some industry settings should be required.  Once in the door, an ASQ certification would helpful.  Some of my colleagues also have Lean Six Sigma certifications to help propel their careers.  Before starting my Masters program at MSM, I considered getting my ASQ certification but realized that's not what I want to do for now.  Although I'm sure it can be rewarding, I'd rather execute the rules than review and enforce them.  

I am actually considering going into regulatory. I do enjoy the more hands on activities that entail a general engineering job, and while paperwork is also not something I am very ecstatic about, the pay is relatively good. Starting you can go between 55k-90k and at the end you can reach around 115k. Along with that, it is a very flexible position and there is tremendous room for growth. Additionally, considering many of us are versed in device development to somewhat of a degree, we know of how to write FDA proposals or documentation for a new device in development, at least I learned from Dr. Tara Alvarez's class and from my own Capstone class. So I would say we are somewhat knowledgeable in this area, which is why it makes us even more qualified to take on regulatory positions, because we know the processes and we know what the final product would look like.

I am not in Regulatory but I've toyed with the idea of moving into it for about a year, after I first heard about it. What attracts me is the opportunity for growth and the possibility of working more remote with a good pay (as a higher position of course). The field interests me as from what I've learned from the lecture, is that while you aren't hands-on with the creation of the product, you would have to know a lot about it and the legal aspects of it. I've browsed through many internet forums to see if I could be a fit for this position/what the day-to-day looks like but still could not reach a consensus for myself. I, personally, am really shy, which is something that I am working on. I'm worried that this weakness would hinder me in a Regulatory position as you pretty much need to be on top of your things, be the enforcer of regulations, and be an excellent and confident communicator.

My question for those in Regulatory would be, is this a skill that you can develop as an entry-level Regulatory Affairs associate? I think I'm not understanding what specific responsibilities an associate would have versus a mid-level or senior position. Some of the responsibilities of Regulatory sound daunting, but those that daunt me seem to be the more senior responsibilities that I'm obviously not qualified for. 

Like most of my peers I have not had a regulatory role and prefer to be able to utilize my engineering background, however, being a successful engineer requires an understanding of good manufacturing practices and good documentation practices according to standard operating procedures which are set in place to ensure that a device intended for commercialization is consistently produced and controlled by the proper quality standards and to maintain compliance with regulatory agency requirements by assuring the traceability and integrity of handwritten/electronic information. I have networked with multiple people within a regulatory role who are very well off because there will always be a need for regulatory experts and it is difficult to replace someone experienced. They are also able to work as consultants, in industry, or as part of agencies such as the FDA. Regulatory agents also get to work on a diverse set of projects, along the way are able to build a large portfolio of work, and truly help build a bridge for translating products from the lab bench to market. In addition to some of the certifications AVParker brought up, I have recently learned about some other certifications such as a regulatory affairs certificate or trainings such as CAPA.

My previous experience was not purely regulatory but had a lot of components of regulatory compliance. Things like quality testing and reporting, verification of weights and measures, and environmental reporting were considered part of my job and required to comply with ISO 9001, HCP, and DEQ regulations. I honestly enjoyed auditing, but you must enjoy the regimented tedium of it. I personally like repeatability and data analysis, which allowed me to enjoy it. There are a lot of advantages to this niche, including employability, job security, and generally good hours. Disadvantages that I noticed included antagonism from your peers (especially if you have to tell them bad news) and less input on product design relative to a R&D position.

Switching from the engineering role to a regulatory role has always interested me because of the perks of the job that other jobs do not have. More and more regulatory roles are becoming remote due to the nature of the work where paperwork and research would be conducted, and most people don't even need to be in the manufacturing environment or on-site. The other benefit that regulatory work provides is the fact that many different types of industries need a regulatory position because few people understand the technical aspects of the paperwork. Regulatory work becomes complicated very quickly because there is confusion in the jargon that is used in this type of work compared to others, where words are simpler and easier to understand. Comparing it to lawyer paperwork is very similar. Another aspect is that within this role there is constant learning about policies that are changed every day, and personally, this piqued my interest because learning is something I want to do in order to have a competitive edge. One of the downsides to this type of work is the constant deadlines that would need to be fulfilled and the fact that many can't help you work in regulatory due to the experience needed. Compared to other industries where there is a larger amount of people available and knowledgeable about topics that can help but cannot be transferred to regulatory If I was offered the chance to work in regulation, I would take it because of the benefits and diversity involved with this type of position.

I come from an engineering background, and the idea of transitioning to a regulatory role did cross my mind. What attracted me to this possibility were the broader perspectives it could offer. As an engineer, I was primarily immersed in the technical aspects of product development, and regulatory work would provide me with a more comprehensive understanding of how products navigate from conception to market, with all the regulatory hurdles and compliance requirements along the way. Moreover, the idea of contributing to product safety and ensuring compliance with quality standards appealed to my sense of responsibility and ethics. Being a point of contact between my company and regulatory agencies like the FDA sounded like a unique opportunity to learn, grow, and influence outcomes. The challenges of problem-solving in the realm of compliance and documentation also piqued my interest. However, after careful reflection, I realized my passion for hands-on engineering work still burned brightly, and the meticulous paperwork involved in regulatory roles might not align with my long-term preferences. That said, I remain open to the idea if the right opportunity comes along, one that allows me to blend my engineering background with regulatory expertise in a way that feels meaningful and fulfilling. Ultimately, it's about pursuing a career path that resonates with my values and strengths.

I have recently switched from an engineering role to a regulatory role, and there are obviously pros and cons to it. Roles in regulatory or compliance usually provide more flexibility to work from home, which some people prefer. Engineering and innovation is necessary and fantastic once delved into, however, what is the point of engineering if all compliance rules are broken? Regulatory and compliance provide the guidelines and framework of of which engineering can take place. This is especially with the presence of FDA regulation in the United States. In my role in regulatory, I learn more about the products, complaints from the field, and actually help research and development in determining what needs to be improved upon. Without quality assurance, a company does not know how its product is performing in the field. Yes, one can argue that it involves more paperwork and mundane/routine tasks, however, there are certain projects that are intriguing and have a company wide effect. These can create a sense of importance and excitement in one's work. Additionally, if someone excels in engineering a certain product at a certain company, his/her skills become in limited in what they know or do for that specific product. However, in a quality assurance role, these skills can be used and spread across different roles and opportunities. 

At first thought, I kind of had the same reaction you did to a career in regulatory, meaning it didn't hold much appeal. But after thinking about it, working in the regulatory field, even if only for a few years, could provide immense benefits to someone working in R&D or engineering. I think knowing the ins and outs of what can be approved by the regulatory bodies before even starting a project can help start a project at the 50 yard line instead of the 20. Tons of great ideas have died over the years because of avoidable decisions made at the start of a project that are just too costly to reverse, and I believe having a solid base of regulatory knowledge can help avoid this issue.

It's a good question. In my opinion, there are several reasons why engineers choose regulatory roles. first of all Broader Impact: Here Engineers have the opportunity to shape the entire lifecycle of a product, from design to market approval. This can provide a broader understandig of the product. Secondly, Leverage Technical Knowledge. While regulatory roles do involve paperwork, engineers bring valuable technical expertise, making them uniquely qualified to understand both the product and the regulatory requirements. Thirdly, Cross-Functional Interaction: Engineers in regulatory roles often work closely with multiple departments providing an opportunity to see the bigger picture within a company.
Key Benefits: i think most important benefit is job stability. Regulatory expertise is in high demand. This translates into job security and opportunities for career advancement.

As an engineering intern at a biomedical equipment manufacturer, I have had the opportunity to perform tasks within the quality assurance and compliance realm, such as modifying SOPs that adhere to ISO18485 and GMP. I tend to have a strong attention to detail and have experience in documentation, as well, so a quality role is definitely appealing to me. Ensuring that a product is presented appropriately in documentation to be submitted to the FDA is one of the most important roles someone can have in the product development process. Working so closely with the FDA would be such a valuable opportunity to get a deep-dive understanding of what it takes throughout the process of bringing an idea to market. 

As a Quality Engineer, I had to the opportunity to perform tasks within Quality Management such as approving and modifying SOPs that adhere to GDP, and making CAD specification drawings for all their parts used in their Diagnostic/Detection Test kits. I have worked with Regulatory, with them constantly having to approve my drawings, before storing them in official folders that will be shown to the FDA. In my experience, the drawings are constantly being reviewed and updated to contain important, relevant information such as material properties, sterilization methods, and printing/mechanical dimensions that are required to be reviewed by the FDA. These revisions and reviews have also led my Quality managers to collaborate with the Purchasing Department to consider buying materials from alternate suppliers due to strict FDA regulations imposed on our devices. Since some of our materials are supplied from external suppliers, those suppliers' products must also adhere to some of the same FDA requirements. I've learned that there's so much that goes on in the development of the device than just the Research and Engineering, and the many obstacles that we can face.

Switching to such career is a recent idea in my mind. I think what attracts me the most to it is the fact that more and more of those positions are becoming remote due to its nature of leaning toward researching and writing. Also, maybe that's what fits me more: a dry-lab kind of work, not having to carry out the wet lab portion. One of the thing that got me into research is how I am really into the mechanism of things, I want to understand how things work and being the one "engineering" something satisfies that. But now, as a position of regulatory person offers, looks like I can also achieve that without having to do the development part? Only one down side I am worried is the writting part, wouldn't it be repetitive and tedious?