Project Specialist

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:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott 

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.  

The Opportunity

This position is an onsite opportunity in the Abbott Diabetes Care Division. We are helping people with Diabetes lead healthier, happier lives.   As a global leader in diabetes care, Abbott is constantly working to deliver the highest quality products and unwavering support to our customers.  Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, so we’re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels.

As a Project Specialist,  you will identify strategies to ensure compliance and meet business needs. This role will support the Program Management and UDI teams by conducting data analysis, conducting project impact assessment,  regulatory gap assessment, actively involve in cross-functional team projects , and developing innovative solutions to complex challenges. This is an onsite opportunity in Alameda, CA.

What You’ll Do

• Assess compliance to world-wide UDI regulations and cross-functional business requirements. Track and report on performance metrics, measuring results against critical success factors.
• Act as a liaison between the cross-functional teams  to establish standards for development and maintenance of enterprise systems.
• Map current processes and perform gap analysis on input & output requirements, data conversion strategies, and system controls.
• Incorporate new and revised requirements from FDA and other worldwide regulations into procedures and quality documentation.
• Identifying data attribute process improvement opportunities.
• Collaborate with internal & external stakeholders  to ensure user requirements are complete, confirming changes and enhancements meet technical specifications and user requirements.
• Lead projects to completion under supervision

Experience You’ll Bring

Required

• Associates Degree
• Minimum 1 year of related work experience with a good understanding of specified functions in a medical device industry and/or multi-division business unit.
• Experience working with Agile, Veeva.

Preferred

• BA or BS degree in technical discipline preferred
• Strong analytical skills with the ability to collect, organize, analyze, an