Regulatory Affairs and Quality Assurance have moved beyond compliance functions. Today, they are critical drivers of speed to market, investor confidence, and commercial success.
With MDR and IVDR transitions, shifting FDA expectations, increased scrutiny of AI-enabled devices, and the financial consequences of warning letters or market withdrawals, the decisions made by VP Regulatory Affairs and QA leaders have never carried greater weight. In FY2024, the FDA issued 47 warning letters to medical device companies - a 96% increase from FY2023. The impact of these events extends beyond lost sales, often affecting market position, investor confidence, and company valuation.
Yet the leaders capable of navigating this environment are increasingly difficult to secure. 29% of MedTech companies cite Regulatory Affairs as their hardest function to hire for. The strongest candidates bring a rare combination of notified body relationships, technical file strategy, post-market surveillance expertise, and quality system leadership across multiple geographies. Finding them requires access to one of MedTech’s most specialized and tightly networked talent pools.