Job Title: Technical Project Manager – Medical Device Labeling Location: Irvine, CA Duration: 6 Months Experience Required: 10+ Years Job Description We are seeking an experienced Technical Project Manager with strong expertise in medical device labeling and regulatory projects. The ideal candidate will act as a Labeling SME, leading cross-functional initiatives, managing labeling systems, and ensuring compliance with industry standards. Key Responsibilities • Provide Labeling SME support for lifecycle management of label templates, artwork, and IFUs • Act as the point of escalation for labeling-related issues • Lead validation activities for enLabel system, including SDLC updates, test script creation, execution, and defect tracking via JIRA • Perform template validation including backend modifications, testing, and integration handling (JDE or similar systems) • Execute Design Change documentation and manage label updates • Work with BOM structures and Windchill (CR/CN execution) • Maintain label design and process knowledge across product platforms • Collaborate with Supply Chain, Quality, Regulatory, and Marketing teams • Lead and manage projects for both planned changes and unplanned events impacting supply continuity • Conduct impact analysis, communication planning, and execution strategies • Drive closure of NC/CAPA activities • Prepare project plans, lead meetings, and provide regular status updates to stakeholders • Manage complex problem-solving and drive continuous improvement initiatives Required Skills • Strong experience in Medical Device Labeling and Regulatory Compliance • Hands-on experience with enLabel system, JIRA, Windchill, Adobe tools • Knowledge of labeling components, governance frameworks, and compliance standards • Experience in NC/CAPA processes and Design Change management • Strong project management and execution skills • Excellent communication, organizational, and stakeholder management skills • Ability to manage multiple priorities and meet deadlines effectively • Proficiency in MS Project, Excel, Word, and other productivity tools