Project Coordinator # JN -062021-66226
Title : Project Coordinator
Location : Plymouth, MN, 55442
Duration : 12+ months contract
- Bachelor's degree plus 2-5 years of related work experience with a good understanding of specified functional area, or Master's degree with 0-2 years of related work experience, or an equivalent combination of education and work experience.
- Knowledge of FDA & EU regulations, GS1 and ISO standards preferred.
- 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.
- Skilled in Microsoft Office specifically Excel, PowerPoint, Word, and Access
- Coordinate project deliverables per project plans.
- Cross functional coordination and management of project deliverables.
- Create and manage labeling change processes within the document management systems.
- Work cross-functionally to identify and resolve labeling inconsistencies to meet applicable requirements and project timelines.
- Performs analysis of Labeling data to support regulatory compliance and cross-functional business requirements.
- 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.