1+ months

Senior Medical Event Specialist

Abbott
Lake Forest, IL 60045

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

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.

Responsibilities:

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.

Minimum Qualifications:

Bachelor’s Degree or Clinical Laboratory / Medical Technologist experience required.

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.

Preferred Qualifications:

Medical Technologist experience with Medical Technologist Certification (e.g. ASCP; AMT; MLT; or similar) preferred.

Working knowledge of the ADD complaint handling process is strongly preferred.","title":"Senior Medical Event SpecialistDivision: ADD Diagnostics
Travel: Yes, 10 % of the Time
Medical Surveillance: No
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Categories

Posted: 2019-11-06 Expires: 2019-12-27

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Senior Medical Event Specialist

Abbott
Lake Forest, IL 60045

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