Executive Summary
The regulatory affairs labor shortage in the United States and Europe is structural, not cyclical — and small-to-mid-sized medical companies are bearing a disproportionate share of the burden.
Where large sponsors can absorb a 50% wage premium to staff senior regulatory professionals, smaller manufacturers face a triple bind: tighter MDR transition pressure, recertification cycles, and a labor market that prices their hires out of reach. The result is that the companies most likely to bring genuine innovation to market are also the ones most likely to be slowed down by a function they cannot adequately staff.
This paper analyzes the size, shape, and trajectory of the SME regulatory crisis — and outlines what AI-native infrastructure can do to close the gap that traditional hiring cannot.
Key Findings
- 68% of small and mid-sized medical manufacturers report material labor shortages in regulatory and quality functions.
- Large pharmaceutical and device companies are paying a 50% wage premium to attract senior regulatory affairs talent, pricing SMBs out of competitive hiring.
- 17% of SMB medical manufacturers still rely on paper-based quality and regulatory systems, compounding the workload of every available professional.
- The MDR and IVDR transitions in Europe have created cyclical recertification pressure that the SMB segment cannot meet through hiring alone.
- The shortage is structural — the educational pipeline produces fewer regulatory affairs graduates per year than annual industry attrition.
Read the full analysis
The full white paper — including methodology, source citations, and detailed analysis of each finding — is available as a downloadable PDF.