Purpose: Under general direction, the Device Tracking Analyst I will perform a variety of complex duties associated with supporting device tracking activities to ensure device tracking files are maintained and reconciled. The Device Tracking Analyst will communicate with customers to obtain and/or verify device tracking information in compliance with device tracking regulations established by the FDA and international regulatory bodies. He/she will facilitate actions identified to improve customer experience and patient safety. He/she will participate and/or lead in the identification and implementation of device tracking management system improvements, including technical support, and updates to procedures and forms used in the device tracking process. Assist globalization of requirements, where necessary. The individual is a subject matter expert due to demonstrated excellence in work performance and mastery of the knowledge, tasks, and skill sets. Works with little to no supervision.
· Process and maintain device tracking files in the device tracking system to support compliance with device tracking regulations and internal procedures. Ability to analyze information for device tracking requirements under 21 CFR 821 and SOR/98-282.
· Initiate device tracking files when forms are received in a timely manner. Maintain and update device tracking system. Record all activity in both hard copy (when applicable) and computer files.
· Maintain a knowledge and understanding of current Device Tracking regulations, Device Tracking guidelines, and Device Tracking interpretations.
· Provide generalized company, departmental and device tracking knowledge as required.
· Coordinate with inter- and intra-departmental customers to ensure device tracking information and inquiries are communicated appropriately.
· Handle sensitive conversations with patients and/or physicians, avoiding litigious or compromising issues, providing information, education and assurance to the patient and/or physician regarding product and service, effectively utilizing “talking points” and communicating corporate policy.
· Support department processes and workflow
· Process outgoing faxes, incoming mail, perform data entry, filing and copying. Initiate and process follow up activities to gather information, submit notifications, etc.
· Inform internal and/or external customers of the device tracking requirements.
· Respond to verbal and written requests from internal and external customers. Initiate and set up complaint files. Maintain and update database. Record all complaint activity in both hard copy (when applicable) and computer files, following complaint handling regulations 21 CFR 820.198, and SOR/98-282, and internal procedures.
· AA degree; Bachelor’s degree is preferred.
· 3 years previous experience in customer service or clinical setting; or equivalent combination of education and experience.
· Knowledge in device tracking policies and requirements. Ability to understand the impact of regulatory compliance requirements (e.g. 21 CFR 821, 21 CFR Part 11, SOR/98/282 and other regulations as they apply)
· Ability to functions in a controlled environment by the FDA and other regulatory authorities. Must have effective written/oral, interpersonal, organizational skills.
· Ability to handle restricted, confidential, private, or personal information in accordance with departmental policies, HIPAA, and related international standards.
· Ability to work effectively with a diverse network of internal and external departments and/or individuals.
· Ability to use word processing, spreadsheet, and database applications. Ability to learn various software programs.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.