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Rose International Project Manager (Medical Device Identifier) in Plymouth, Minnesota

Position Title: Project Manager (Medical Device Identifier) Position Number: 368302 Location: Plymouth, MN 55442 Position Type: Long Term Contract Required Skill Set: ERP, FDA, Medical device, Project Management, Project Plans, Project Schedule, SAP Position Description: **Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.** Job Title: Project Manager (Medical Device Identifier) Requirement Number: 13798 Start date: 6/21/2022 Duration or End date: 12 Months Location: Plymouth, MN 55442 Hours: Shift to be determined, operating hours are between 8:00am - 5:00pm CST Job Overview: The Labeling Systems and Data Project Manager will be responsible for meeting business needs by supporting the Labeling and Unique Device Identification (UDI) teams by leading/implementing projects, conducting analysis, developing managing master data, communicating with cross functional teams, and problem-solving various challenges. KEY RESPONSIBILITIES Project manage deliverables per project plans. Create and manage labeling and UDI change processes within the document management systems. Create and modify product labels or other labeling materials ensuring compliance to all regulatory, legal, and medical requirements following the established design format, labeling style, and branding guidelines. Work cross-functionally to identify and resolve labeling and UDI inconsistencies to meet applicable requirements and project timelines. Facilitates end-user training and assists in identifying resolution business and technical problems. Performs analysis and audits of UDI & or Labeling data to support regulatory compliance and cross-functional business requirements. Manage Labeling and UDI master data and workflow via internal IT systems. Manages concurrent deadlines and meets deadlines for assigned work/tasks. Analyze and interpret large data sets and identify methods of resolution. Complies to world-wide Labeling and UDI regulations and cross-functional business requirements. Comply with company initiatives in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), FDA & world-wide regulations, business requirements, company policies and operating procedures. QUALIFICATIONS BA or BS degree in communications, regulatory, business, mathematics or equivalent combination of education and work experience. Project Management certification or coursework preferred. Ability to manage projects and drive them to completion with attention to detail. Requires ability to be innovative, resourceful, and work with minimal direction. Knowledge of FDA & EU regulations, GS1 and ISO standards. Strong written and verbal communication, at all organizational levels. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Experience working in medical device industry with focuses on regulatory compliance, quality systems, labeling, or UDI preferred. Experience working with ERP and/or PLM systems preferred. Preferably SAP and/or Windchill. Database management and/or analytics software knowledge preferred. Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy. Skilled in Microsoft Office specifically Excel, PowerPoint, Word, and Access. Benefits: For information and details on employment benefits offered, visit here. If you have any questions/concerns, please contact our HR Department via our secured website. Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francis