Risk Management Process Professional

at Abbott in Lake Forest, Illinois, United States

Job Description

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 115,000 colleagues serve people in more than 160 countries.

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 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 .

+ Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

+ 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 for our facility in Lake Forest IL or Irving TX in the Diagnostics Division.

We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

What You’ll Work On

The Risk Management Process Professional is responsible for leading all aspects of Risk Management for a project from start to finish so that it is completed on time and supports project needs.

- Lead the Cross Functional Discussions to develop and maintain Risk Management Files.

- Can serve as a Risk Management Process Community member and/or process owner alternate.

- Tracks progress and drives completion of all deliverables associated with Risk Management.


- Lead the CFT to drive appropriate risk approaches to product design decisions. Track approval of Risk Management deliverables and ensure content reflects reasonable reduction of risk.

- Directs project execution by facilitating the creation of RMF content through assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans.

- Drives resolution of project issues by working with team members, project customers, and others as appropriate.

- Estimates project leads of effort and resource requirements by working with appropriate staff to understand scope of effort.

- Interfaces with and presents issues and solutions to senior management on significant matters.

- Mentor, coach, and train new product development teams to create or maintain product risk assessments.

- Responsible for implementing and maintaining the effectiveness of the Risk Management Quality System element.

- Interprets regulations and requirements and implements procedural requirements to meet requirements as they pertain to the project.

- Serves as a representative during internal and external inspections and inquiries from regulators such as FDA, ISO, and AQR as it relates to R&D RMFs.

Required Qualifications

Education: Bachelor’s Degree (± 16 years) Relevant field.

Experience/Background: Minimum 7 years of experience, both overall and any industry-specific experience needed.

Preferred Qualifications

Licenses and Certifications

Working knowledge of ISO 14971 and application to IVD products. Technical knowledge of the products and ability to influence product development decisions to reduce risk.

  • Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: (

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 , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $90,700.00 – $181,300.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email

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Job Posting: JC247782975

Posted On: Sep 14, 2023

Updated On: Nov 30, 2023

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