Senior Manager Medical Operations

Abbott; United States; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health coverage (HIP PPO)

Tuition reimbursement

Education benefit (FreeU)

Retirement plan contribution

Career development

Recognition as great place to work

Job summary

Abbott in Irving, TX is seeking a Senior Manager, Medical Operations to lead medical affairs across the IVD product lifecycle. You will provide clinical expertise to product development, regulatory compliance, risk management, and post‑market activities, partnering with R&D, Regulatory, Quality, Clinical, and Commercial teams.

You will guide clinical safety and risk assessments, represent Medical Operations in cross‑functional teams, and drive medical reviews for investigations, complaints, and

Qualifications

• Advanced scientific, clinical, or medical background in IVD/diagnostics or life sciences.
• Strong knowledge of medical affairs, clinical evaluation, risk management and product development.
• Experience supporting cross-functional teams in regulated healthcare environments.
• Ability to translate complex clinical and scientific data into actionable insights.

Responsibilities

• Provide expert medical and clinical assessments of IVD products, including assay performance and clinical impact.
• Serve as the Medical Operations SME across the product lifecycle including development and post‑market activities.
• Lead clinical safety and risk assessments and contribute to risk management documentation.
• Represent Medical Operations in cross‑functional teams and communicate insights to stakeholders.
• Support investigations, CAPAs, complaints, and field actions with medical reviews.
• Manage and prioritize Medical Operations activities and team workload.
• Develop and deliver training programs to strengthen medical and scientific capabilities.
• Drive continuous improvement of Medical Operations processes and systems.

Skills

Medical operations expertise

Clinical evaluation

Risk management

Cross-functional collaboration

Education

PhD in Life Sciences or MD

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 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 and quality teams.
• Manage and prioritize Medical Operations activities, ensuring effective execution of objectives, workload distribution, and team performance.
• Develop and deliver training programs that strengthen medical, clinical, and scientific capabilities across the organization.
• Drive continuous improvement initiatives by evaluating and enhancing medical operations processes, procedures, and systems.

Required Qualifications

Doctorate Degree PhD in Life Sciences, immunology, or Clinical / translational research or MD

Minimum 7 years of experience

Preferred Qualifications

• Advanced scientific, clinical, or medical background with expertise in IVD, diagnostics, medical devices, biotechnology, or life sciences.
• Strong knowledge of medical affairs, clinical evaluation, risk management, product development, and/or post‑market surveillance activities.
• Experience supporting cross‑functional teams in regulated healthcare environments.
• Proven ability to translate complex clinical and scientific data into actionable bu