Family and friends often ask about my job in Regulatory Affairs and what it is that I do. When I begin explaining, they usually get a puzzled look that tells me what they are thinking:
- "Regulatory" means "something involving rules or policing" and
- "Affairs" means... "what you're doing when you cheat on your spouse."
In a matter of seconds, it becomes clear that my friends and family have no idea what it is that I do for a living.
So let's clear this up. Regulatory Affairs professionals don't cheat on their spouses (not in a professional capacity, anyway). But we do tend to disrupt old, comfortable ways of doing things in order to help open our clients up to exciting possibilities. So perhaps we have more in common with a fiery mistress or hunky boy toy than we might suspect.
So what is a regulatory affair? Should you have one?
If you are a small medical device or diagnostics company working towards the goal of marketing your product in the U.S. and/or most international markets - then the answer is clearly YES! If you are operating in this space but are a large company with IVD products already on the market then you probably have already had regulatory affairs.
Regulatory Affairs professionals help you create a regulatory strategy for your product in the markets you intend to launch. They also can help guide and support product development efforts to ensure products are designed to meet FDA and other regulatory requirements. They can help you develop and maintain a compliant quality management system which is required for device manufacturers doing business in the U.S. and most other countries around the globe. An experienced regulatory affairs professional brings a broad range of skills to help you reach your companies goals. They do not police your efforts but instead provide leadership and experience to assist and support your organization in bringing your technology to the diagnostic market in a compliant fashion. They can also help guide you back on the compliance path if you have regulatory issues related to your product's regulatory status or your company's advertising and promotional practices.
I like to think of the Regulatory Affairs professional as an interpreter or facilitator that bridges the gap in understanding between device manufacturer's and the regulatory bodies or agencies that regulate them. They are skilled at helping both sides understand each other and negotiating outcomes that meet the objectives of both parties. In the end their job is to assist in the process of bringing the latest and greatest science and technology to the physicians and patients they care for. At the end of their day that is what really matters and what makes the regulatory affair worth the effort.
A regulatory affair can be an exciting way to broaden your company's horizons. Best of all, you don't have to wait seven years or leave town on a business trip. You can have a regulatory affair right now. Just don't expect your family to understand what you're doing.
Tags: 510(k), Advertising & Promotion, Careers, IVD, QSR, regulatory affairs
