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PDS Tech Inc Labeling Support in Fremont, California

PDS Tech, Inc. is seeking Labeling Support

Key Responsibilities

Identify solutions for the Clinical, NPD, Sustaining and customer-facing (OEM) labeling change request to meet ISO and IVDR requirements:

  • Provide definition to the requestor and cross-functional representatives with labeling design requirements while establishing agreement on content, format and artifact (e.g., IFUs, Labels, Implant Cards, and Operations Manuals) solutions for moderately complex labeling change packages.

  • Review workflow expectations and milestones to achieve results to ensure alignment with business strategy, comply with labeling quality systems and meet customer expectations with ability to reach consensus on priorities and target completion dates.

  • Identify, evaluate, make recommendations and execute labeling change; request tasks to assure alignment with project solution and requested target dates:

  • Provide recommendations and regular report out on activities and issues resolution of various business scenarios. Prepare, review and approve labeling intake documentation. Provide guidance to labeling team on identification and execution of typical solutions with accelerate timetables for critical projects.

  • Develop and maintain timetables for creation of new and revisions to existing labeling content and format in a cost-effective manner. Partner with team members to ensure label change package execution aligns with project deliverables.

  • Support sections of process improvement projects and propose solutions. Identify and define gaps, revise verbiage to clarify, improve/enhance and/or correct relevant procedures and provide guidance and training as needed.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.