Product Performance Clinical Lead

Abbott's Electrophysiology division seeks a clinical leader to oversee regulatory reporting decisions and guide a small team in Plymouth, Minnesota. The role bridges clinical expertise with product performance, ensuring compliance across global regulatory bodies for cardiac device portfolios.

Responsibilities

• Serve as clinical and technical liaison between medical community and Product Performance Group
• Determine product complaint reportability to regulatory bodies using clinical expertise and product knowledge
• Lead and train small team on regulatory compliance, patient physiology, and product use
• Review complaint files for compliance and develop rationales for regulatory reporting decisions
• Support continuous process improvement and coordinate solutions for workflow enhancements

Requirements

• Healthcare professional background in nursing or biomedical engineering
• Knowledge of cardiac disease states and patient physiology
• Strong verbal and written communication skills across organizational levels
• Experience in catheterization lab, hospital, or medical device settings
• FDA medical device reporting regulations knowledge
• Ability to manage multiple tasks independently while collaborating across departments