Senior Regulatory Affairs Manager in Regulatory Operations Group Smith+Nephew
The regulatory environment for MedTech is evolving rapidly through the application of technology, creating urgency for Regulatory Affairs teams to modernize their Regulatory Information Management (RIM) systems. During this session regulatory experts introduce a six-tier RIM Maturity Model to help organizations assess their current state and chart a path toward optimization. Industry leader Smith & Nephew has implemented this model and will provide insights into its RIM maturity journey. Drawing on data from the 2024 World Class RIM Study and a real-world case study, the discussion will highlight practical steps for phased RIM transformation. Attendees will learn how to move from manual, reactive processes to strategic, technology-enabled regulatory operations.
Learning Objectives:
Understand the six levels of RIM maturity and how to evaluate your organization’s current state.
Learn practical strategies for implementing a scalable and phased RIM system transformation.
Gain insights from Smith & Nephew’s experience to improve stakeholder alignment and change management.
