About Ultrasound AI Ultrasound AI is an FDA-authorized medical AI company developing technology that helps obstetric providers improve pregnancy care. Our flagship product, Delivery Date AI, analyzes standard ultrasound images inside existing clinical imaging workflows and received FDA De Novo authorization in 2026 (DEN250007). We are a lean, venture-backed team with eight issued patents, operations in the U.S., Brazil, and Chile, and an active Series A raise underway. Our first 510(k) is under FDA review, with more planned behind it. About the role This is the senior regulatory seat in the company, reporting to the CEO. You own regulatory strategy, every interaction with FDA, and the quality management system behind each submission. The work is concrete. A 510(k) for Delivery Date AI was submitted to FDA in August 2026; you will take over that review as our official correspondent

• acceptance review, substantive interaction, Additional Information requests
• through to a decision.

Behind it:

a pipeline of follow-on 510(k)s using our De Novo-granted device as the predicate, and a QMS you will take through

ISO 13485

certification under FDA's QMSR. Our founder drafts submissions with AI tooling and moves fast. Your job is to make them right: set the strategy, redline the drafts, decide what evidence is actually needed, and carry each submission through FDA. You will lead the Quality, Regulatory & Compliance function

• an in-house Regulatory Affairs Specialist plus outside consultants. What you will own FDA strategy and interaction
• predicate and substantial-equivalence strategy, Pre-Submissions, e

STAR 510

(k)s, Additional Information responses, and every call with the review team The 510(k) pipeline

• a repeatable path from new algorithm or indication to submission; Predetermined Change Control Plans (PCCPs) for model updates; and the call on when a software change needs a new 510(k) Evidence and submission content
• deciding what performance and clinical evidence each submission needs, shaping study design with our CMO, and co-authoring or redlining device descriptions, software (IEC 62304) and cybersecurity documentation, risk management (ISO 14971), and labeling The QMS
• design controls and the Design History File, CAPA, complaint handling and medical device reporting (21 CFR 803), post-market surveillance, software change control for a cloud-delivered SaMD, management review, and internal audits under QMSR (21 CFR Part 820) and

ISO 13485

2016, as management representative;

ISO 13485

certification and FDA inspection readiness Claims governance and the regulatory roadmap

• every marketing, sales, investor, and customer statement stays inside what FDA authorized, and the board knows what we can claim, when, and what it will take What you bring 5+ years in medical device regulatory affairs, including 2+ years with software as a medical device (SaMD) or AI/ML-enabled devices Multiple 510(k)s you personally authored or led through FDA review to a decision, including resolving Additional Information requests or a deficiency letter Experience as a company's official correspondent with FDA, including Pre-Submission meetings Ownership of a QMS through an

ISO 13485

certification audit or an FDA inspection

• not participation, ownership Working knowledge of eSTAR, the 510(k) and QMSR regulations, medical device reporting, ISO 13485, ISO 14971, IEC 62304, and FDA's current guidance on AI-enabled devices, PCCPs, cybersecurity, and software documentation Clear, precise writing; comfort using AI tools to draft and check regulatory work while owning the judgment behind it; and the ability to tell the difference between real regulatory risk and paperwork How you work The traits that matter most, in the order we notice them: Radical integrity: transparency, ethical accountability, and honesty even when it is uncomfortable•with FDA and with us.

Detail oriented and proactive:

you catch the error before it ships and raise the problem before it is one.

A self-starter:

when something is unclear, you find the answer or propose one.

A strong problem solver:

the interesting parts of this job have no procedure yet. Comfortable in a fast-paced environment where priorities move day to day. Team oriented, with a positive attitude: a small team cannot afford friction. Nice to have De Novo experience, or 510(k)s that used a De Novo-granted device as the predicate Ultrasound, radiology, or obstetric AI;

DICOM/PACS

workflows; a granted

PCCP RAC

(Devices) or

ISO 13485

lead auditor credentials; eQMS experience (we use Qualityze)

ANVISA, EU

MDR, or Health Canada submissions; Portuguese or Spanish The contract-to-hire path We intend to convert this role to full-time. The contract phase exists because we are closing a Series A, and because both sides should see how we work under live FDA review before a long-term commitment. Expect an initial term of up to six months at $80

• $175 per hour depending on experience, 40 hours per week, with conversion tied to clear milestones: command of the pending 510(k) review, an audit-ready QMS, and the same mutual-fit test any executive hire faces.

On conversion:

$130,000

• $275,000 base salary depending on experience, plus equity, health insurance, 401(k), and paid time off. The right person can grow significantly with the company as responsibilities expand. In person in Greenwood Village, Colorado; Denver-metro area candidates. How to apply Apply through Indeed with your resume and a short note
• a few sentences on each of three things: 1. A 510(k) you led, the hardest question FDA asked, and how you resolved it. 2. How you would approach using a De Novo-granted device as the predicate for follow-on 510(k)s on the same platform. 3. A QMS you kept audit-ready with a small team
• what broke, and what you fixed.

We read every application. Applications are reviewed as they arrive; we anticipate closing this posting on October 16, 2026. Equal opportunity Ultrasound AI, Inc. is an equal opportunity employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. If you need an accommodation during the hiring process, contact bob@ultrasound.ai.

Pay:

$80.00

• $175.

00 per hour Expected hours: 40.0 per week

Benefits:

401(k) Health insurance Paid time off People with a criminal record are encouraged to apply

Experience:

510(k) submissions: 1 year (Preferred) medical device regulatory affairs: 5 years (Preferred)

Work Location:

In person