Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Plymouth, MN location in the Structural Heart division. 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 UDI Analyst, you’ll be responsible for meeting business needs by supporting the Labeling and UDI teams by conducting analysis, managing master data, communicating with cross functional teams, and problem-solving various challenges.
What You’ll Work On
- Create and manage UDI change processes within the document management systems.
- Work cross-functionally to identify and resolve labeling and UDI inconsistencies 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.
- Manages concurrent deadlines and meets deadlines for assigned work/tasks.
- Analyze and interpret large data sets and identify methods of resolution.
- Complies to world-wide Labeling and UDI regulations and cross-functional business requirements.
- Supports UDI inquiries at internal and external audits.
- Trained on and engaged in CAPA activities.
- 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
- Bachelors Degree in communications, regulatory, business, mathematics or an equivalent combination of education and work experience.
- Minimum 1 year related 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.
- 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.
Preferred Qualifications
- 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.
- Experience utilizing labeling/graphical design software and/or graphical tools such as CAD, Adobe Illustrator/Photoshop or other related software preferred.
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$50,000.00 – $100,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Regulatory Operations
DIVISION:SH Structural Heart
LOCATION:United States > Minnesota > Plymouth : 5050 Nathan Lane N
ADDITIONAL LOCATIONS:
WORK SHIFT:Standard
TRAVEL:No
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Top Skills
What We Do
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
