1099 consultant · ~80–400 hrs per funded award · $115–$170/hr · Remote (U.S.)

Regulatory Affairs & FDA Submissions Subject-Matter Expert

Keep our medical software and device work correct on the regulatory pathway — what FDA will require, in what order, and what it will cost.

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About Precision Federal

Precision Federal is a Christian-owned small business building AI and software systems for federal agencies through the SBIR program. The founder is a Christian, and the company is run on Christian principles: every number we publish is real, every claim we make is verifiable, and the work is done with excellence as service to God. Every proposal we submit is backed by working prototypes built before we ask for a dollar.

How this role works

You join the bench. We name you (with a short bio) on proposals that match this role, always asking you first. Consent costs you nothing and commits you to nothing until an award funds.
A contract is awarded. Federal SBIR awards fund the team named in the proposal. Your engagement begins, at an hourly rate agreed before you were ever named.
You work remote, paid from the contract. ~40–80 hrs per funded award — and if no award ever funds, you owe nothing and lose nothing.

What you'll do

Map the regulatory pathway for a proposed capability and say what evidence each step demands
Advise on Software as a Medical Device, clinical decision support boundaries and predicate strategy
Review our quality-system and documentation approach against what an auditor expects
Tell us when a claim we want to make would change the device classification

Required qualifications

Direct experience preparing or supporting FDA submissions — 510(k), De Novo, PMA, IDE or IND
Working knowledge of Software as a Medical Device and applicable FDA guidance
U.S. citizen or lawful permanent resident (U.S. person)
Willing to be named on a federal proposal with a one-page resume, and to sign a short letter of commitment

Preferred qualifications

Regulatory Affairs Certification (RAC) or equivalent
ISO 13485, IEC 62304 or 21 CFR Part 820 quality systems
AI/ML-enabled device experience and the Predetermined Change Control Plan framework
BARDA, MTEC, DHA or comparable federal medical program experience

Compensation & structure

1099 consulting engagement. $85–$125 per hour, confirmed in writing before you are named on any proposal. Hours are funded by federal contract awards — engagements on this bench have ranged from roughly 130 to 710 hours across a period of performance, fully remote. Work and pay begin only if the contract is awarded — no award, no hours, no obligation.

Apply — Regulatory Affairs & FDA Submissions Subject-Matter Expert

Every application is read personally by the founder. We respond to every serious one.

First name *

Last name *

Email *

Phone

City & state

Years of relevant experience *

Work authorization *

Security clearance

Military service

LinkedIn or portfolio link

Resume (PDF or Word) *

How did you hear about us?

Five questions

These are the substance of the application. Answer from your own experience — a few sentences each is plenty, and “this never came up” is a real answer we want.

1. How often does a species record set turn out to be incomplete or mis-keyed once you start working with it, and roughly what does that cost to discover late — in hours, people, or rework? *

2. What tools or data sources does your organization use today to assemble species occurrence and status information, and where do they fall short? *

3. If a better way to assemble and quality-check species records existed, which office or role would decide whether to adopt it? *

4. Do you have any role in deciding what tools, data sources, or methods your organization adopts — approving, evaluating, or recommending? *

5. Do you own, or hold signing authority for, a company or consultancy of your own? *

May we credit you by name and title in our federal proposals? *

Questions before applying? [email protected] · See all open roles