Sr Manager, Global Labeling Devices
Core
Lead the development and implementation of labelling strategies and content for medical devices and combination products, ensuring compliance with global regulatory requirements.
Role type
Senior Manager, Regulatory Affairs (Medical Devices)
Builds
Instructions for Use (IFU) and device labelling content for global markets
Domain
Medical Devices / Regulatory Affairs
Required skills
Global regulatory strategy, IFU development, cross-functional leadership, risk mitigation, stakeholder presentation, US/EU regulatory compliance
Preferred skills
Combination product experience, matrix environment navigation, advanced scientific degree
Technologies
Regulatory frameworks (US/EU), Combination product development tools
Responsibilities
Lead end-to-end development of IFU and labelling content, drive cross-functional alignment on labelling strategy, present strategies to senior leadership, ensure compliance with US and EU regulations, manage global exceptions and local affiliate alignment
Seniority
Senior, hands-on IC with leadership responsibilities