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Abbott Laboratories3 weeks ago

Senior Specialist, Product Performance, Medical Affairs

$99,300–$198,700 year

On-site · Santa Clara, California, United States or Temecula, California, United States

Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Enterprise

Job Summary

Senior Specialist Clinical Product Performance at Abbott Vascular, based in Temecula, CA or Santa Clara, CA. You will oversee on-market product performance, post-market surveillance, and clinical study product performance, including analysis of post-market data, customer complaints, and MDR reporting. You will design and implement risk management and product performance assessment improvements, collaborate cross-functionally with Compliance, Clinical Science, Regulatory Affairs, Medical Affairs and Commercial teams, ensure regulatory reporting and compliance, provide scientifically balanced medical information, and support investigations of complaints with data from clinical staff, field representatives, and laboratories. You will contribute to developing strategies for the division’s medical oversight product performance function, monitor safety signals, and communicate findings to internal and external stakeholders while navigating regulatory requirements. Requires a Bachelor's degree in a health-related field, 5+ years of relevant experience, and ability to travel up to ~10% (including international). The role emphasizes cross-functional collaboration, quality compliance, risk management, and the translation of clinical data into actionable insights for product safety and performance.

Required Qualifications

  • Bachelors Degree in Pharmacy, Nursing, RT, Life Science, or other health-related field, or equivalent qualification
  • 5+ years of relevant experience
  • A background in cardiology, cardiac surgery or vascular medicine/surgery is preferred
  • Experience working in a quality related role, or equivalent time in clinical laboratory, medical clinic, or nursing experience
  • Preferred: MD, RN or RT with Cath Lab experience
  • Strong ability to work cross functionally, understand various needs across diverse functions, and prioritize work according to business unit needs
  • Experience prioritizing and managing project initiatives across multiple functions and/or business units
  • Ability to travel, potentially approximately 10%, including internationally
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$99k – $199k / yr

Senior Specialist, Product Performance, Medical Affairs · Abbott Laboratories

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