This document summarizes research from a benchmarking study of regulatory affairs practices at 32 leading medical device companies. Key findings include: - Regulatory affairs structures are most commonly centralized, though some utilize decentralized or hybrid models. Larger companies tend towards more decentralized structures. - Portfolio complexity, defined as the ratio of class III products, influences but does not solely determine staffing needs. - On average, companies file over a dozen submissions annually with European regulators and over 60 submissions with Japanese regulators. - Regulatory staff spend significant time (over 20% for most companies) managing change notices and documentation.