Device Tracking Analyst II
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
Under general direction, the Device Tracking Analyst II 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.
Specific job duties include:
- 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.
- 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.
- 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.
- Assist in the coordination of department personnel regarding device tracking and/or complaint handling activities to ensure compliance with applicable regulations.
- Develop training content.
- Train new staff and conduct training/re-training on company policies, Device Tracking regulations, complaint handling regulations, and departmental practices.
- Support the department on special projects as needed.
- Assist in device tracking audit activities.
- Support regulatory inspections.
Education and Experience
- AA degree, with five years previous experience in regulatory, quality, clinical, or related customer service setting; or equivalent combination of education and experience. Bachelor's degree is strongly preferred.
Essential Knowledge and Skills
- 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 function 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.
- Knowledge of clinical, surgical techniques and procedures, and medical terminology.
- 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.
- Skill in demonstrating a professional phone manner.
- Effective communication with physicians and nurses as required.
- Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts.
- Ability to respond to common inquires or complaints from customers, regulatory agencies, or members of the business community.
- Ability to take initiative and make decisions.
- Ability to demonstrate leadership in job performance by example.
- Ability to accurately perform detail-oriented work.
- Ability to be flexible in changing daily workload priorities as directed.
- Ability to maintain accuracy, consistency, and quality in a fast-paced, multi-task environment.
- Ability to coordinate and synchronize multiple projects.
- Ability to monitor and coordinate department workloads.
- Ability to develop and deliver training.
- Ability to manage a high-volume case load.
- Ability to think critically and analytically.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.