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Switching to a Regulatory Career

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7 Users
Posts: 78
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While majority of us come from engineering backgrounds and lean towards a more "hands-on" career, we did learn about possible career choices that might be an option in the Regulatory field. With additional degrees and the proper certifications, a successful career could be possible. I do prefer more of an engineering career because I do not really enjoy being involved in paperwork and documentation so I do not think a career in regulation is for me. However it would be interesting to take on a different role and be able to serve as a contact between a company and the FDA and being involved in how a  product goes from idea to market, so I would never say never if the right opportunity came along. 

Have any of you switched over to or considered a more regulatory role coming from an engineering background? If so, why, and what benefits greatly stood out to you. 


Posted : 26/09/2021 5:41 pm
Posts: 39
Eminent Member

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!

Posted : 26/09/2021 7:18 pm
Posts: 26
Eminent Member

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.  

Posted : 11/07/2022 8:37 pm
Posts: 25
Eminent Member

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.

Posted : 30/09/2022 3:07 pm
Posts: 39
Eminent Member

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. 

Posted : 01/10/2022 8:04 pm
Posts: 81
Trusted Member

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.

Posted : 01/10/2022 11:42 pm
Posts: 36
Eminent Member

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.

Posted : 02/10/2022 3:09 pm