Responsibilities
* Create and manage labeling and UDI change processes within the document management systems.
* Create and modify product labels or other labeling materials ensuring compliance with all regulatory, legal and medical requirements following the established design format.
* Address labeling and UDI inconsistencies to meet applicable requirements and project timelines.
* Facilitate end-user training and assist in identifying resolution for business and technical problems.
* Perform analysis and audits of UDI and/or labeling data to support regulatory compliance and cross-functional business requirements.
* Manage UDI master data and workflow via internal IT systems.
* Manage concurrent deadlines and meet deadlines for assigned work/tasks.
* Analyze and interpret large data sets and identify methods of resolution.
* Comply with worldwide labeling and UDI regulations and cross-functional business requirements.
* Support company initiatives in quality management systems (QMS), environmental management systems (EMS), RDA and worldwide regulations, business requirements, company policies, and operating procedures.
Requirements
* Exempt/Non Exempt: non exempt
* Years Experience: 2-5
* Skills: Verbal and written communication, attention to detail, results driven, innovative, resourceful, teamwork, individual contributor, multitask, strong organizational, advanced computer skills
* Education: Bachelor level degree in Communications, Regulatory, Business, Mathematics or equivalent combination of education and work experience.
EEO
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
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