Abbott Post Market Medical Device Reporting Specialist in Lake Forest, Illinois
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 73,000 people. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
Primary Job Function
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 non-conformances or potential non-conformances in the medical event reporting process are identified; documented; and resolved through effective CAPA implementation and monitoring. Lead initiatives for continuous process improvements.
Core Job 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 non-conformances or potential non-conformances 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.
The above statements are intended to describe the general nature and level of work being performed; other duties may be performed as assigned.
Position Accountability / Scope
Accountable for making medical device reportability decisions and preparing clear; accurate; and timely medical event reports to be submitted directly to regulatory authorities. This position is responsible for global compliance of medical device reports submitted to US and International Authorities.
Bachelor’s 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
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.
JOB FAMILY: Compliance/Regulatory Affairs
DIVISION: ADD Diagnostics
LOCATION: United States >Lake Forest : CP01 Floor-1
WORK SHIFT: Standard
MEDICAL SURVEILLANCE: No
SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.