Manager Medical Operations
About The Position
The Manager of Medical Operations (Medical Affairs) leads medical affairs activities across the in vitro diagnostics (IVD) product lifecycle. The role provides scientific and clinical expertise supporting product development, regulatory compliance, risk management, and post-market activities. It partners with R&D, Regulatory Affairs, Quality, Clinical, and Commercial teams to integrate clinical and medical considerations into business decisions and product strategy. The position provides medical and clinical subject-matter knowledge for new product development, on-market projects, and risk management. It helps maintain a medical perspective across processes, projects, and initiatives to support the safety and performance of Abbott products throughout their lifecycle. The role is based in Abbott’s Core Labs Division, with locations listed in Irving, Texas, and Lake Forest, and includes travel of 15% of the time.
Requirements
- Doctorate degree (PhD) in Life Sciences, immunology, or clinical/translational research, or an MD.
- Minimum 3 years of experience.
Nice To Haves
- 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.
- Ability to translate complex clinical and scientific data into actionable business recommendations.
- Strong leadership, stakeholder management, communication, and presentation skills.
Responsibilities
- Provide expert medical and clinical assessments of IVD products, including assay performance, clinical utility, and patient impact, and ensure medical requirements are incorporated into product development and lifecycle management.
- Serve as the Medical Operations subject-matter expert, supporting new product development and on-market products through clinical review, evaluation, and strategic guidance.
- Support clinical safety and risk assessments, including benefit-risk evaluations, risk management documentation, and clinical evidence packages.
- Represent Medical Operations on cross-functional project teams and communicate medical insights and recommendations 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.
- Support Medical Operations activities, including effective execution of objectives, workload distribution, and team performance.
Benefits
- Career development opportunities with an international company.
- Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- Retirement savings plan with a high employer contribution.
- Tuition reimbursement.
- Freedom 2 Save student debt program.
- FreeU education benefit, providing an affordable and convenient path to a bachelor’s degree.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
Ph.D. or professional degree
