Getting Started in the Regulatory Writing Field

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A technical writer in the Greater Boston area sent me the following email.


I am interested in a career move, to the field of regulatory writing for medical devices. I feel that my software development experience, attention to detail and technical skills would transition well to this endeavor.

I am looking for suggestions for training or certificates that would prepare me for this field. What type of training do people look for when they are hiring for regulatory writing? I appreciate any suggestions you can provide.

Signed, Career Move

I’ve been working in the regulatory writing field since 1992 and TRA360 has had a regulatory writing practice since 1997 so I had some ideas to share. Here they are:

Dear Career Move,

Regarding your career move into regulatory writing for medical devices, two options come to mind, both of which lead to a certificate: academic coursework and a professional program. On the academic side, I would check into courses and certificate programs at some of the Greater Boston area colleges and universities: Northeastern, Wentworth Institute of Technology, Mass College of Pharmacy, Worcester Polytechnic Institute, UMass Boston, University of Lowell, MassBay Community College, Bunker Hill Community College, and Roxbury Community College come immediately to mind. I would expect that they would have both online and on-ground offerings.

Depending on the time and money you choose to invest, you can look into a more full-fledged program such as the Graduate Biomedical Writing program offered at the University of the Sciences in Philadelphia.

On the professional side, you might consider organizations like Regulatory Affairs Professional Society and Drug Information Association. I just went to the RAPS website and they have an online Regulatory Affairs Certificate: Medical Devices certificate that might be of interest.

Let me know if these resources are of value. If you find any others, please share them with me.



Does anyone know of other resources that might be of value to Career Move?