Medical Affairs Leader, Diagnostics & IVD 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 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