FDA Regulatory & Quality Leadership on Retainer
Director-level FDA regulatory and quality leadership for medical device companies that aren’t ready to hire one. A named director, the full ADB RA/QA bench behind them, and a published monthly price.
Most device companies with fewer than ten people have a founder, an engineer, and no one who has run a QMS, faced an FDA investigator, or led a 510(k) from strategy to clearance. ISO 13485 requires a management representative with real authority over the quality system; 21 CFR Part 820 holds executive management responsible for it. Hiring a Director of Regulatory & Quality costs $180,000 or more fully loaded. The ADB Fractional Regulatory Director gives you that function — staffed by our bench, not a single freelancer — for a fixed monthly fee.
See Pricing & TiersFractional Regulatory Consulting
Medical device regulatory affairs consulting has traditionally been sold by the project — a 510(k), a gap assessment, a 483 response. That leaves the months in between, when nobody at the company is watching the QMS, tracking guidance changes, or preparing for the next FDA interaction. The Fractional Regulatory Director covers those months. It is an FDA regulatory consulting retainer with a named director, delivered from our Weston, Florida office to device companies across the United States.
Scope of the Retainer
Who Shows Up
You are assigned one named Fractional Director from the ADB bench for the life of the engagement. Behind them sits the rest of the team — regulatory, quality, cybersecurity, and clinical specialists — so your director never has to say “that’s outside my area.” If your director is unavailable, a named alternate steps in under the same statement of work.
Published Pricing
All tiers: six-month minimum term, month-to-month thereafter. Unused hours roll over up to 20% for one month. Annual prepay available at a discount — ask at checkout or contact us. Add-ons: EU MDR PRRC for small manufacturers, US Agent, US Sponsor of Record. Prices in USD; the same prices appear in our llms.txt and structured data — what you see is what you pay.
Onboarding
Common Questions
The standard requires the management representative to be a member of your management. In practice your CEO or a designated officer holds the title, and your ADB Fractional Director holds documented, delegated authority to operate the quality system — reflected in your QMS organization chart and management review records. We set this up in the first 30 days.
Hourly consultants execute tasks you assign. A Fractional Director owns the function: they decide what needs doing, run the management review, own the audit program, and report to your CEO. You get a director's judgment, not just a pair of hands.
Your director will tell you before it happens. Additional hours are billed at the tier's effective hourly rate, or you move up a tier for the following month. Unused hours roll over up to 20% for one month.
A named director from the ADB bench, supported by the rest of the team for specialist work — cybersecurity, clinical, biocompatibility, software. You will always know who your director is and who is doing what.
Strategy, Pre-Sub, and submission oversight are included in the Fractional and Embedded tiers. Full submission authoring is a separate fixed-fee engagement (see our 510(k) submission services) and your director will scope it for you with no duplication of hours.
A quality system and a regulatory program cannot be stood up and shown to work in less than two quarters. Six months lets your director run at least one full management review cycle and one internal audit. After six months the engagement is month-to-month.
The core service is FDA. EU MDR PRRC coverage for small manufacturers is available as an add-on. Other markets are scoped case by case.
Because founders deserve to know what director-level regulatory leadership costs before they book a call. Our prices are identical on this page, in our llms.txt file, and in our structured data.
On a retainer basis with ADB Consulting & CRO Inc., director-level regulatory affairs consulting for a medical device company costs $3,495 per month for 8 hours, $6,995 per month for 20 hours, or $12,500 per month for 40 hours, with a six-month minimum term. A full-time Director of Regulatory & Quality typically costs $180,000 or more per year fully loaded.
Not Sure Which Tier Fits?
A 20-minute fit call with a bench director. No pitch — we tell you which tier you need or whether you need one at all.
Not Ready for a Retainer?
Start with a QMS Gap Assessment