Regulatory Writing/Consultation-A Career Upgrade for Technical Communicators–Part 1

I have been active in the technical writing field for more than 20 years and I have met more than a few writers who feel blocked in their career path both in terms of interest and money. One alternative that uses many of the same skill sets used in technical communication is the regulatory field.

My personal story is a good illustration of this. I was working a freelance technical writer for a start-up company that was developing a new type of imaging device to be used in the operating room. The device was quite large and complicated and required (to my delight)  a several hundred page manual. In addition, for the company to survive it needed to receive regulatory approval from the FDA to market its device. Due to the novel approach of this device the approval was far from automatic. Because it was kind of difficult to get clear explanations about the system from many of the engineers (sound familiar?) I began asking the VP of regulatory affairs. He was not a native English speaker and he then asked me to  go over some documents that he wrote to check the English. I asked him what each document was for and he provided me with good explanations of various aspects of the regulatory process and I spent more and more time helping him with the FDA submission. The company got the FDA approval, began marketing it device in the US and was eventually bought out by the multinational medical device company Medtronic. I leveraged my knowledge of preparation of regulatory documents to find more gigs and soon had enough experience to be able to honestly present myself as a regulatory consultant. I established my own company Carmel Scientific where I offer regulatory consulting and medical and technical writing services. The VP regulatory affairs left the company to set up his own consulting firm and I have been working with him as a subcontractor for the past 17 years.

In my next entry I’ll compare the two fields and offer advice on how to make the switch.

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