Job Title-Labeling Specialist Location-Plymouth, MN Pay range-$23/hr-$25/hr
Bachelor’s degree in
Communications, Regulatory Affairs, Business, Mathematics , or an equivalent combination of education and relevant work experience.
Key Duties & Responsibilities
Create and manage
labeling and UDI (Unique Device Identification) change processes
within document management systems
Develop, revise, and maintain
product labels and labeling materials
in compliance with regulatory, legal, and medical requirements and established design standards
Identify and resolve
labeling and UDI inconsistencies
to meet regulatory requirements and project timelines
Manage
UDI master data and workflows
through internal IT systems
Perform
analysis and audits of UDI and labeling data
to support regulatory compliance and cross-functional business needs
Analyze and interpret
large datasets
to identify issues and recommend resolution methods
Facilitate
end-user training
and assist in resolving business and technical issues related to labeling and UDI systems
Manage multiple priorities and
meet concurrent deadlines
for assigned tasks
Ensure compliance with
global labeling and UDI regulations , Quality Management Systems (QMS), Environmental Management Systems (EMS), RDA requirements, company policies, and operating procedures
Collaborate cross-functionally to support regulatory, quality, and business requirements
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Communications, Regulatory Affairs, Business, Mathematics , or an equivalent combination of education and relevant work experience.
Key Duties & Responsibilities
Create and manage
labeling and UDI (Unique Device Identification) change processes
within document management systems
Develop, revise, and maintain
product labels and labeling materials
in compliance with regulatory, legal, and medical requirements and established design standards
Identify and resolve
labeling and UDI inconsistencies
to meet regulatory requirements and project timelines
Manage
UDI master data and workflows
through internal IT systems
Perform
analysis and audits of UDI and labeling data
to support regulatory compliance and cross-functional business needs
Analyze and interpret
large datasets
to identify issues and recommend resolution methods
Facilitate
end-user training
and assist in resolving business and technical issues related to labeling and UDI systems
Manage multiple priorities and
meet concurrent deadlines
for assigned tasks
Ensure compliance with
global labeling and UDI regulations , Quality Management Systems (QMS), Environmental Management Systems (EMS), RDA requirements, company policies, and operating procedures
Collaborate cross-functionally to support regulatory, quality, and business requirements
#J-18808-Ljbffr