Sr Manager, Global Labeling Devices
Core
Lead end-to-end development and maintenance of Instructions for Use (IFU) and device labelling content for medical devices and combination products, ensuring compliance with global regulatory requirements.
Role type
Senior Manager, Regulatory Affairs (Medical Devices & Combination Products)
Builds
Global labelling strategies and compliant IFU content for medical devices and drug-device combinations
Domain
Pharmaceuticals and Medical Devices (Regulatory Affairs)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory strategy, IFU development, cross-functional leadership, risk mitigation, stakeholder presentation, US/EU regulatory compliance, combination product expertise
Preferred skills
Advanced degree in scientific discipline, prior medical device experience, pharma regulatory background
Technologies
None stated
Responsibilities
Lead end-to-end development and maintenance of Instructions for Use (IFU) and device labelling content; Drive cross-functional collaboration to align labelling strategy and ensure regulatory compliance; Develop labelling strategies for combination drug/device products and standalone devices; Lead and facilitate labelling working groups and drive decision-making across global stakeholders; Present labelling recommendations, risks, and strategies to senior leadership and governance forums; Ensure labelling content complies with US and EU regulatory requirements and aligns with global regulatory strategy; Support labelling submissions, updates, and implementation of new scientific, clinical, or safety data; Partner with local affiliates to ensure alignment with global labelling and manage exceptions where required; Proactively identify risks and propose mitigation strategies related to labelling content and implementation
Seniority
Senior Manager, strategic leadership & cross-functional alignment
