Labeling Project Manager
Core
Lead and implement labeling and Universal Addendum Labeling (UAL) projects to meet business needs and regulatory requirements for medical devices.
Role type
Senior project manager (labeling and regulatory compliance)
Builds
Labeling and UAL change processes, master data workflows, and program deliverables
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
product features
Required skills
Program management methodologies, cross-functional communication, risk management, data analysis, regulatory compliance knowledge, ERP/PLM system management, database management, analytical skills
Preferred skills
Medical device industry experience, FDA/EU regulations knowledge, GS1/ISO standards, SAP/Windchill experience, analytics software knowledge
Technologies
SAP, Windchill, Microsoft Excel, PowerPoint, Word, Access
Responsibilities
Develop and drive detailed schedules and timelines for program deliverables; Create and manage labeling and UAL change processes; Identify and resolve labeling inconsistencies; Monitor program risks and drive resolution; Manage Labeling and UAL master data and workflow; Analyze large data sets to identify resolution methods
Seniority
Senior, hands-on IC
