Sr Manager, Regulatory Affairs

Job description

Job Summary: The Senior Regulatory Affairs Manager will lead regulatory strategy and compliance activities across the EU, with a strong focus on enabling commercial success through effective tender participation and market access. This role requires deep expertise in EU MDR, CE marking, EUDAMED, and UDI, along with hands-on experience working with Notified Bodies and regulatory authorities. The individual will act as a strategic partner to Commercial, Contracts, and cross-functional teams, providing regulatory insight to interpret complex tender requirements, identify compliance gaps, and develop practical solutions to win business. This role demands strong technical knowledge in EU labeling, eIFU, and promotional compliance, as well as the ability to implement processes, train teams, and translate evolving regulations into actionable business strategies. A successful candidate will combine regulatory expertise, business acumen, and strategic thinking to drive compliant growth, ensure competitive positioning, and support sustainable expansion across European markets. Duties & Responsibilities: - Lead and execute regulatory strategy to support market access and commercial growth acr...