Javier Lopez
Product Lifecycle Labeling Analyst @Mentor Worldwide Llc
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WORK HISTORY
Product Lifecycle Labeling Analyst @Mentor Worldwide Llc
Irving, TX, US
Lead cross-functional teams to execute compliant labeling changes across multiple product families. • • Ensure design inputs are accurately captured and documented per franchise and regulatory procedures. • • Deliver complete labeling packages to design control teams, reducing cycle time and improving compliance accuracy. • • Partner with business units to resolve labeling issues, ensuring clarity, risk mitigation, and on-time project execution. • • Collaborate with peers to enhance labeling processes and drive continuous improvement initiatives. • Proofread/Copy edit to ensure labeling is error-free, clear and concise. • eIFU/ePIL Content Administrator – uploading eIFU’s and ePILs to company website using Veeva Vault and INDEX platforms.
SKILLS
ABOUT JAVIER LOPEZ
Regulatory Associate professional with experience in labeling for the medical device industry, as well as in the cosmetic and supplement industry. Review and perform critical analysis of compliance to domestic and international regulatory requirements for direct to consumer advertisements, continuing education material and investigational patient/physician recruitment material. Have a great work ethic and always a positive attitude regardless of the situation.Specialties: Review and approve labeling for both domestic and international use. Liaison for various departments gathering data for submissions and customer service. eIFU/ePIL Content Administrator using Veeva Vault and INDEX.
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