Cardiac monitoring company · Regulatory and Quality
The first regulatory and quality leader a company ever hired
A cardiac monitoring company moving into its own proprietary hardware, with three devices in the pipeline, needed someone to build a quality management system from nothing and own regulatory alongside it, alone. The budget was also below market, which the search had to resolve before it could close.
- 66
- days to accepted offer
- 133
- candidates targeted
- 7
- presented
This was the first dedicated regulatory and quality hire in the company's history, created as it began bringing its own hardware to market. The person would architect the entire quality management system from scratch and own both regulatory and quality with no team around them. That rules out most of the function, which is staffed by people who maintain a system somebody else built.
Non-negotiables
- Class II device experience with hands-on 510(k) submissions, ideally in cardiac monitoring, cardiology devices or digital health
- Has built or substantially scaled a quality management system personally, not supervised one
- Comfortable owning regulatory and quality together, without a team
- A builder rather than a maintainer, in a lean and entrepreneurial environment
- 01
Direct targeting against a named list
Rather than advertising, the search targeted 133 specific people who had done this particular job, screening on tenure and on whether they had built rather than inherited a system.
- 02
Told the client the budget was wrong
Compensation benchmarking showed the profile the client wanted cost significantly more than the budget allowed. That went back to the hiring manager as market feedback early, rather than being discovered by a declined offer two months later.
- 03
Heavy, continuous market feedback
The hiring manager heard what the market was actually saying throughout, so the brief and the package moved together instead of the search quietly failing against a fixed one.
133 candidates targeted, 7 presented
A deliberately narrow shortlist from a wide, named target list.
3 advanced to first-round interviews
All three had built a quality system from scratch themselves.
66 days from sourcing to accepted offer
Including the time taken to rebenchmark compensation mid-search.
The function now has a team forming under it
The client returned to FloodGate for an engineer and a regulatory specialist who report to this hire.
The cost of a bad talent decision is almost always greater than the cost of the hire itself.
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