Abbott Senior Medical Event Specialist in Lake Forest, Illinois
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
- Job Description Summary
Comply with relevant US and International regulatory requirements through the timely review; documentation; and filing of global ADD medical complaints. Ensure the safety and effectiveness of products in the field by interfacing with other functional areas (e.g. Customer Service and Site Quality) responsible for complaint handling and evaluations and highlighting potential medical; clinical and/or safety issues with ADD products. Ensure that nonconformances or potential nonconformances in the medical event reporting process are identified; documented; and resolved through effective CAPA implementation and monitoring. Lead initiatives for continuous process improvements.
Responsible for implementing and maintaining the effectiveness of the quality system.
Review medical complaints; document filing decision rationale; and submit medical event reports in compliance with FDA regulations and International Regulatory requirements within the required timeframes.
Ensure medical event file documentation is clear; concise; and adheres to compliance requirements.
Identify any nonconformances or potential nonconformances in a timely manner; ensure thorough documentation; and aid in the development of comprehensive CAPA strategies to prevent recurrence.
Provide subject matter expertise and training; as needed; to other functional areas (e.g. Customer Service and Support and Quality) responsible for identifying and resolving potential medical; clinical and /or safety issues.
Lead projects or initiatives to improve the compliance and/or efficiency of the medical event reporting process.
Bachelors Degree or Clinical Laboratory / Medical Technologist experience required. Medical Technologist
experience with Medical Technologist Certification (e.g. ASCP; AMT; MLT; or similar) preferred.
Minimum Experience / Training Required
Indicate the minimum experience level and/or training required to perform this job.
Minimum of 6 years combined experience as a medical event specialist, a medical technologist in a clinical
laboratory setting, and/or a strong technical role (Technical Support, complaint handling, etc.) with ADD
products is required. Working knowledge of the ADD complaint handling process is strongly preferred.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com