Risk Manager

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

Job summary

Abbott in Dallas, TX, within the Core Lab, Diagnostics Division, seeks a Risk Manager to serve as the SME for risk management quality systems.

You will develop methods and tools for risk activities, interpret global regulations, mentor engineering teams, and interface with regulators such as FDA and ISO to ensure compliance.

This role requires strong project leadership, cross-functional collaboration, and a deep understanding of ISO 14971 and medical device risk processes.

Qualifications

• Bachelors degree Life Science or engineering; equivalent experience accepted.
• 8–10 years in product safety risk management across R&D, NPD, ops or compliance.
• Experience with risk management (ISO 14971) required.

Responsibilities

• Develop methods, tools, and procedures for risk management activities.
• Maintain effectiveness of the Risk Management Quality System element.
• Interpret regulations worldwide and implement risk management programs.
• SME for domestic/international sites and affiliates on Risk Management.
• Estimate effort and resources; manage tasks and timelines; identify risks.
• Interface with senior management and coordinate across units on significant matters.
• Represent the company during FDA/ISO/AQR inspections related to risk management.
• Mentor product development and sustaining engineering teams on risk assessments.
• Mentor engineering staff to prepare Health Risk Assessments.

Skills

Risk management

Regulatory compliance

Project leadership

Cross-functional collaboration

Education

Bachelor’s degree Life Science/Engineering

Master’s degree preferred

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 122,000 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 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.

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.

JOB FAMILY:

Operations Quality

DIVISION:

CRLB Core Lab

LOCATION:

United States > Irving : LC-8

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % of the Time

MEDICAL SURVEILLANCE:

No

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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf