Labeling Specialist
5050 Nathan Lane North Plymouth, MN 55442 US
Job Description
*Depending on experience
Description:
Exempt/Non Exempt: non exempt
Years Experience: 5-7
Skills: Verbal and written communication, attention to detail, results driven, innovative, resourceful, team work, individual contributor, multi task, strong organizational, advanced computer skills
Education: Bachelor level degree in Communications, Regulatory, Business, Mathematics or equivalent combination of education and work experience.
Duties: 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 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 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), RDA & world-wide regulations, business requirements, company policies, and operating procedures.
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