Associate Medical Director

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 facilities in 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

WHAT YOU’LL DO

The Associate Medical Director, Medical Product support, Global Medical Operations:

• Provide Medical Affairs Support for Core Diagnostics instruments/platforms (ie, Architect, Alinity) and Professional Services Business Unit (AlinIQ, AMS) during the product life cycle including submissions to regulatory agencies.
• On-Market support includes updating existing documents (including Product Requirements and Risk Management documentation) and providing required input to Post-Market Risk Evaluation process.
• Research and Development support includes assisting in the development of User Needs, Product Requirements, Risk Management File contents, Instructions For Use, Verification and Validation records, etc. for instruments, software, middleware, and informatics products.
• Assist Medical Directors in preparing Medical Platform Documents and Medical Opinions to support product development.
• Participates in cross functional teams related to complaints and adverse events, AE reporting, risk analysis and safety monitoring.
• Provide expert opinion regarding laboratory operations, regulations, workflow and needs.
• Provide references and information to support Medical Opinions or Health Hazard Assessments for on-market product issues.
• Provide concise, clear and accurate medical input into design control activities.
• Work under supervision of Medical Director to identify and elevate any significant issues.
• Provide timely responses to prevent delay in project timelines.

Required Qualifications

• Medical Degree from an accredited institution.
• 3 years+ of clinical experience.

Preferred Qualifications

• 3+ years’ experience with medical software and automation products in a clinical laboratory setting
• Experience with clinical informatics obtained via accredited Clinical/Medical Informatics fellowship or at least 2 years working experience in Clinical/Medical Informatics
• Product development experience including risk management, product requirements, verification/validation
• Familiarity with regulations governing the above (FDA, CE Mark, ISO, IVDR, etc.)
• 1-2 years Medical Device or Diagnostics industry experience

* 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:  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 $118,000.00 – $236,000.00. In specific locations, the pay range may vary from the range posted.

• clinical experience
• medical affairs
• clinical informatics
• medical operations
• medical informatics
• development
• medical science
• medical software
• fda
• clinical laboratory
• ams
• product support
• product life cycle
• risk management
• iso
• informatics
• product development
• risk analysis