The Universal Addendum Labeling (UAL)/Unique Device Identification (UDI) Specialist will be responsible for meeting business needs by supporting the multiple UAL and UDI systems by conducting analysis, developing medical device labels, managing master data, creating complex addendum label configurations, and problem-solving various challenges.
* 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 UAL and UDI inconsistencies or configuration challenges 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.
* 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.
* Support UAL process, data and system management
* Creation and implementation of addendum labels ensuring compliance to all regulatory, legal, and medical requirements following the established design format, labeling style, and branding guidelines
* On-time delivery of project work/tasks across multiple businesses with concurrent deadlines
* Support UAL workflow via internal IT systems
* BA or BS degree in communications, regulatory, business, mathematics, data analytics or equivalent combination of education and work experience.
* 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.