Turn complex medical device, regulatory, and cybersecurity material into clear, structured, submission-ready documentation for 510(k) and other premarket submissions.
Blue Goat Cyber is expanding, and we are looking for a Regulatory Affairs Technical Writer who can turn complex medical device, regulatory, and cybersecurity information into clear, structured, submission-ready documentation. This role supports medical device manufacturers by drafting and coordinating cybersecurity documentation for 510(k) and other premarket submissions, while keeping architecture, risk, controls, testing evidence, and regulatory expectations aligned.
This role is ideal for someone who understands medical devices and regulatory affairs, writes exceptionally well, learns quickly, and can confidently work with clients and internal technical teams. You will work from Blue Goat Cyber templates and methodology, review client source material, identify gaps early, and produce accurate documentation aligned with current FDA guidance.
This is a full-time employee role requiring strong written and verbal communication, independent ownership, attention to detail, and the ability to manage multiple documents and client projects at once. You must be available for weekly internal meetings and client meetings as scheduled.
What success looks like early on, so you know what you are walking into.
Blue Goat Cyber is a medical device cybersecurity company dedicated to protecting patient lives by securing the technologies that power modern healthcare. We support medical device manufacturers as they build, test, and launch secure devices that meet FDA expectations and operate safely in the real world.
We are a remote, high-trust, high-ownership team that values clear communication, rigorous thinking, proactive problem solving, continuous learning, and attention to critical details. We expect every team member to own their work, communicate clearly, and support the mission without ego.
The terms every person here works under. Read them now rather than at offer stage, along with our core values and the honest list of who this is not for. See also what excellence looks like here, the eight standards we hire against.
Send your resume, any links to your work, and a short note about why this role fits. It takes a few minutes and a real person on our team reads every application.
If you do not hear back within two weeks, we have decided not to move forward for now. We keep applications on file for future openings.
