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 Irving, TX location in the Core Labs Division.
Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
About the Role
As the Sr. Manager, Medical Operations , you will lead medical affairs activities across the in vitro diagnostics (IVD) product lifecycle, providing scientific and clinical expertise that supports product development, regulatory compliance, risk management, and post-market activities. You will partner closely with R&D, Regulatory Affairs, Quality, Clinical, and Commercial teams to ensure clinical and medical considerations are effectively integrated into business decisions and product strategy.
What You’ll Work On
The Senior Manager of Medical Operations (aka Medical Affairs) provides Medical and Clinical subject-matter knowledge and support to all product lifecycle activities and processes, including new product development, on-market projects/activities, and risk management. This role helps maintain the medical perspective in all processes, projects, and initiatives, which ensure the safety and performance of Abbott products throughout the lifecycle.
This is an excellent opportunity for a technical medical affairs leader who thrives at the intersection of clinical science, risk management, and diagnostic product innovation while influencing products from concept through commercialization and post-market support.
Provide expert medical and clinical assessments of IVD products, including assay performance, clinical utility, and patient impact, ensuring medical requirements are incorporated throughout product development and lifecycle management.
Serve as the subject matter expert for Medical Operations, supporting both new product development and on-market products through clinical review, evaluation, and strategic guidance.
Lead clinical safety and risk assessments, contributing to key deliverables such as benefit-risk evaluations, risk management documentation, and clinical evidence packages.
Represent Medical Operations in cross-functional project teams, communicating medical insights and recommendations to stakeholders through presentations, reviews, and strategic discussions.
Support investigations, CAPAs, complaints, and field actions by providing medical review and clinical impact assessments in collaboration with Medical Directors…