New 
Device Tracking Analyst
 Spectraforce Technologies | |
 United States, Illinois, North Chicago | |
 Apr 15, 2025 | |
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Job Title: Device Tracking Analyst
Location: North Chicago, Illinois 60085 (Hybrid) Duration: 06 Months (Possible Extension) Description: 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. Key Duties and Responsibilities: Describe Scope: % of Time or Importance 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. * Ability to monitor several files at once, including status and follow-up as necessary. * 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. * Ability to identify non-complaint customers and forward to management for resolution. 25% Provide assistance with various departmental projects that may include: * Write/revise department procedures as assigned. * 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. Job Qualifications (Minimum Requirements): The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job. Education and Experience : AA degree, with three to 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 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. * Ability to communicate effectively, both verbally and in writing. * 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. What are the top 3-5 skills, experience or education required for this position: Critical thinking skills to problem solve or identify when to escalate Ability/experience in working both independently and as a team Experience in working in a controlled/regulated environment (e.g. federal/state regulations, privacy) Experience in customer service, especially communicating sensitive information over phone in email with tough calls Minimum associate's degree: bachelor degree preferred | |