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Abbott · 2 days ago

Business Analyst II - Labeling

United States - Minnesota - Plymouth

Full-time

Onsite

Mid Level

$61K/yr - $123K/yr

3+ years exp

Abbott is a global healthcare leader focused on improving quality of life. The Labeling Business Analyst II will support compliance strategies and manage data while collaborating with cross-functional teams to solve various challenges in labeling and unique device identification.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

H1B Sponsor Likely

Responsibilities

Acquire data from primary and secondary data sources and maintain databases. Analyze and interpret data sets and identify methods of resolution

Manages concurrent deadlines and meets deadlines for assigned work/tasks. Plan, lead, and implement projects of varying size

Assess compliance to world-wide UDI regulations and cross-functional business requirements

Track and report on performance metrics, measuring results against critical success factors

Manage Labeling and UDI master data and workflow via internal IT systems. Execute test protocols, maintain or create departmental work instructions, facilitate end-user training and assists in identifying resolutions business and technical problems

Collaborate with internal & external customers, contractors, and vendors to ensure user requirements are complete confirming changes and enhancements meet technical specifications and user requirements

Research technology trends and new developments in order to identify efficient methods of accomplishing business and information systems goals

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

Qualification

Regulatory complianceLabelingUDISAPWindchillAnalytical skillsMicrosoft ExcelProject managementCommunication skillsTeamwork

Required

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, or other analytics and database management software

Knowledge of FDA & EU regulations, GS1 and ISO standards

Ability to manage projects and drive them to completion

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

Preferred

BA or BS degree in technical discipline preferred, or equivalent combination of education and work experience

3 – 5 years' technical experience in a medical device industry and/or multi-division business unit 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

Benefits

Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year

An excellent retirement savings plan with a high employer contribution

Tuition reimbursement

The Freedom 2 Save student debt program

FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree

Company

Abbott

Glassdoor3.8

Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.

Founded in 1888

Illinois City, Illinois, USA

10001+ employees

https://www.abbott.com

H1B Sponsorship

Abbott has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (1)