The Opportunity

This position works out of our Plymouth, MN location in the SH division.

Structural Heart Business Mission : why we exist

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

As the Labeling Specialist I, you'll have the chance to be responsible for supporting the UAL system by conducting analysis across multiple systems, developing compliant international medical device labels, managing label data and creating complex addendum label configurations.

Detailed communication with cross functional teams and problem-solving across multiple businesses are key skillsets.

What You’ll Work On

• 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
• Analysis and interpretation of large data sets and issue resolution
• On-time delivery of project work / tasks across multiple businesses with concurrent deadlines
• Work cross-functionally to identify and resolve labeling and configurations challenges in order to meet deliverables and timelines
• Support UAL workflow via internal IT systems
• Comply 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

Required Qualifications

• BA or BS degree in mathematics, data management, engineering or equivalent combination of education and work experience.
• Strong written and verbal communication, at all organizational levels.
• Ability to manage projects and drive them to completion with attention to detail.
• Requires ability to be innovative, resourceful, and work with minimal direction.
• 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.

Last updated : 2024-05-10