Careers | Director of Regulatory Affairs
Director of Regulatory Affairs
Become an integral part of the leadership team of a startup taking an innovative medical diagnostic platform through initial regulatory approval, market launch and product scale-up. You will lead a critical role within the company leading regulatory operations.
We are a can-do organization and are seeking candidates who want to jump in and add value. The right candidate for this job has:
An appetite for risk. Brevitest is a startup with huge ambitions and a high likelihood of falling short of those ambitions. This is not a job for someone who fears failure.
A willingness to work. This job is only for people who want to get their hands dirty. It will be like jumping into a raft running the rapids – you’ll need to grab an oar and get to work. We like people who have mad skills and are still humble.
An obsession with getting things organized. You need to think strategically and also execute tactically. If you like to make lists and check things off of them by getting things done, you might be right for Brevitest.
A passion for excellence and team spirit. We are a close-knit group. We’ve spent a lot of late nights and weekends getting to where we are. We want someone who shares our goals and can help us execute in a highly regulated space.
- People skills. Who matters more than what, and we want people who share this prioritization and act that way. You know, able to disagree without being disagreeable.
Knowledge and proven experience that will help us win. The more you know about the following, the more you can help:
- FDA regulations – this is the biggie. You will be responsible for drafting documents we submit to the FDA, organizing pre-subs, interfacing with the agency, coordinating our stable of FDA consultants, and anything else needed to help us navigate the 501(k) and EUA approval processes. We are innovators who respect regulators, so need someone who can help us communicate effectively with them.
- Clinical trial design and execution for in-vitro diagnostics
- An understanding of CLIA regulations medical device manufacturing would be nice to have since we run a reference lab and would need to work collaboratively with them on strategy and execution.
Experience & Educational Requirements:
10+ years’ experience in the medical devices regulatory field. We are open to educational background, but if you don’t have some kind of a science or engineering background you might get lost pretty quickly. We work collaboratively and many on our team have advanced degrees. You need to be able to lead and follow, give and receive feedback and redirection. Sure, we got a lot of smart people, but being smart is not the same as being right, so you gotta be willing to tell someone smarter than you that their idea is stupid.
Position is based in Houston and we want you to physically work here in the office—not remotely. You must be fluent in English and able to legally work in the US without sponsorship.
It’ll be ok, you won’t get rich off of your salary and bonus. If we win big, you will too with your equity. That’s what we are aiming for.
Company Overview | Brevitest Technologies LLC
Brevitest Technologies, Inc (“Brevitest”), a portfolio company of Fannin Partners, LLC, has been developing a pioneering “diagnostics as a service” platform that can run medium-complexity, rapid, quantitative immunoassays at or near the point of care for such analytes as opioids, PSA, TSH and vitamin D. You can check out our website, brevitest.com but we’re kinda in semi-stealth mode so you won’t learn much.
Please send us your resume and a statement of interest that tells us why you think you are our person and we are your company to Andrea Letkeman at email@example.com. Keep it to 400 words or less–pithy and poignant.