Risk Manager

Abbott Laboratories; Irving (TX); On-site; USD 99,000 - 199,000; Full time

Benefits offered by this job

HIP PPO Medical plan

Retirement plan

Tuition reimbursement

Job summary

Abbott Laboratories in Dallas, TX is seeking a Risk Manager to serve as the Division SME for Risk Management quality systems worldwide. You will develop methods and oversee implementation, mentor engineering teams, and ensure compliance with ISO 14971 across the Diagnostics Division.

The role partners with cross‑functional teams to assess risk, plan resources, and coordinate inspections by regulators such as FDA and ISO, contributing to safer medical devices and healthier futures.

Qualifications

• Bachelor's degree in life sciences or engineering; related experience acceptable.
• 8-10 years of experience in product safety risk management across R&D, manufacturing, operations or compliant handling.
• Experience with risk management (ISO 14971) required.

Responsibilities

• Develop methods, tools, and procedures for risk management activities.
• Implement and maintain the Risk Management Quality System element.
• Interpret regulations and implement programs worldwide for Risk Management.
• Serve as SME for domestic and international sites regarding Risk Management Quality System element.
• Mentor, coach and train engineering staff to prepare Health Risk Assessments.

Skills

Risk management

ISO 14971

Regulatory knowledge

Education

Bachelor's degree Life Science or engineering

Master's degree (preferred)

Job description

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 works out of our Dallas, TX location in the Core Lab, 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.

The Risk Manager will be Division Subject Matter Expert (SME) for the development and implementation of the quality systems and/or quality subsystems and/or key process(es) pertaining to Risk Management.

What You’ll Work On

• Develop methods, tools, and procedures to conduct risk management activities
• Responsible for implementing and maintaining the effectiveness of the Risk Management Quality System element.
• Interprets regulations and requirements and implements programs and procedures to meet requirements worldwide as they pertain to Risk Management.
• SME for domestic/international sites and affiliates regarding Risk Management Quality System element.
• Estimates project levels of effort and resource requirements by working with appropriate staff to understand scope of effort.
• Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans.
• Resolves project issues by working with team members, project customers, and others as appropriate.
• Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units.
• Serves as a representative during internal and external inspections and inquiries from regulators such as FDA; ISO; and AQR as it relates to product Risk Management.
• Mentor, coach and train new product development teams and sustaining engineering teams to create or maintain product risk assessments.
• Mentor, coach and train engineering staff to prepare Health Risk Assessments.

Required Qualifications

• Bachelors Degree Life Science or engineering degree preferred to understand and interpret technical issues, or an equivalent combination of education and work experience.
• 8-10 year experience in product safety risk management in researching/engineering, new product development, operations and /or compliant handling.
• Experience with risk management (ISO 14971) required.

Preferred Qualifications

• Masters Degree is preferred
• Experience should include work with regulations and standards related to medical devices as it relates to product design, development and testing.
• Knowledge of devices used for PTCA and PTA is desirable.
• Knowledge of various tools and techniques for Risk Management is desirable.
• Knowledge of IEC60601-1 or electrical safety is desirable.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://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 abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

The base pay for this position is $99,300.00 – $198,700.00. In specific locations, the pay range may vary from the range posted.