SaMD consultant vs. in-house regulatory hire

A consultant is built for episodic, high-stakes decisions: classification and qualification, QMS and architecture design, notified body selection, and the specific judgment calls that only come up once or twice in a product’s life but are expensive to get wrong. An in-house regulatory hire is built for continuous operation: running the QMS day to day, maintaining the risk file as the product changes, handling complaint intake and CAPA, and being the person the organisation turns to reflexively rather than on a schedule. Neither is a smaller version of the other — they solve different problems, and a company that only has one of them is missing whichever half it lacks.

Pre-seed through an early funded stage, before a QMS is operating and before there is enough daily regulatory work to occupy a full-time person, a consultant is almost always the better economics: the decisions that matter most — qualification, classification, initial architecture — are exactly the episodic, high-judgment kind a consultant is suited to, and a full-time hire in this window is frequently underutilised on the actual work while still carrying full-time cost and equity.

Once the QMS is operating, the product is shipping, and EU MDR’s Article 15 requirement for a Person Responsible for Regulatory Compliance becomes a live obligation rather than a future one, the calculus flips. At that point the company needs someone embedded enough to own the quality system, sign off on changes under change control, and be accountable to a notified body directly — which is structurally an internal role, even where external expertise still gets consulted on specific decisions.

In practice, the two roles overlap rather than hand off cleanly. Many companies bring in a consultant to make the foundational classification and architecture decisions, then hire internally once there is enough steady operational load to justify the role — with the consultant often involved in defining what that internal role needs to own and helping evaluate candidates for it, since regulatory affairs hiring is a specialised skill founders rarely have in-house judgment for on a first hire. The consultant relationship frequently continues at lower intensity after the internal hire starts, for the genuinely episodic decisions — a new market, a significant architecture change, a notified body escalation — that don’t justify a second internal specialist.

Is there already enough steady-state regulatory and quality work to occupy someone full time, or is the immediate need a handful of foundational decisions? Does the company currently have anyone with the judgment to evaluate a regulatory hire’s competence, or would that hire be the company’s first point of internal expertise with no way to check their work? And is the QMS itself designed yet — because hiring someone to operate a quality system that doesn’t exist yet in any real form is usually premature regardless of stage.

For companies at the earliest, pre-funding stage, a short conversation through our pro-bono mentoring is often enough to work out which side of this you’re actually on. Once there is a funded programme and real decisions to make, that becomes the scope of our SaMD regulatory strategy advisory — including, where it’s useful, helping define and staff the internal role this guide describes.