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Abbott

Makes heart devices, glucose sensors and lab tests

Manager Medical Operations

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-time$99.3k - $198.7k

About the Job

Requirements

  • A doctorate degree, specifically a PhD in Life Sciences, Immunology, or Clinical/Translational Research, or an MD, is required.
  • A minimum of 3 years of experience is required.
  • An advanced scientific, clinical, or medical background with expertise in in vitro diagnostics, diagnostics, medical devices, biotechnology, or life sciences is preferred.
  • Knowledge of medical affairs, clinical evaluation, risk management, product development, and/or post-market surveillance activities is preferred.
  • Experience supporting cross-functional teams in regulated healthcare environments is preferred.
  • Ability to translate complex clinical and scientific data into actionable business recommendations is preferred.
  • Leadership, stakeholder management, communication, and presentation skills are preferred.

Responsibilities

  • Lead medical affairs activities across the in vitro diagnostics product lifecycle, providing scientific and clinical expertise to support product development, regulatory compliance, risk management, and post-market activities.
  • Provide medical and clinical subject-matter knowledge and support to product lifecycle activities and processes, including new product development, on-market projects and activities, and risk management.
  • Maintain a medical perspective in processes, projects, and initiatives to help ensure product safety and performance throughout the lifecycle.
  • Provide expert medical and clinical assessments of in vitro diagnostics products, including assay performance, clinical utility, and patient impact, and ensure medical requirements are incorporated throughout 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 in cross-functional project teams and communicate medical insights and recommendations through presentations, reviews, and strategic discussions.
  • Support investigations, corrective and preventive actions, 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 execution of objectives, workload distribution, and team performance.

Desired Qualifications

  • An advanced scientific, clinical, or medical background with expertise in in vitro diagnostics, diagnostics, medical devices, biotechnology, or life sciences.
  • 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.
  • Leadership, stakeholder management, communication, and presentation skills.

About the Company

Abbott

Makes heart devices, glucose sensors and lab tests

Abbott makes medical devices, diagnostic tests, nutrition products and branded generic drugs for hospitals, laboratories, pharmacies and patients. Its best-known product is the FreeStyle Libre, a coin-sized sensor worn on the upper arm that tracks blood sugar around the clock without routine finger pricks. Its other lines run from heart valves, pacemakers and brain stimulators to lab analyzers, rapid tests and mail-in colon cancer screening kits, and Abbott earns money by selling these products to health systems, labs, retailers and consumers. The company was founded in 1888 by Chicago physician Wallace Abbott and is based in Abbott Park, Illinois.

Company size
10,001+
Company stage
IPO
Headquarters
Abbott Park, IL
Founded
1888

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