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Kelly Services Device Tracking Analyst in Waukegan, Illinois

JOB SUMMARY:

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. The employee must conduct their work activities in compliance with all internal requirements and with all applicable regulatory requirements, including knowledge of operating in a controlled environment. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

KEY DUTIES AND RESPONSIBILITIES:

  • 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. 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 and internal procedures. Ability to identify non-complaint customers and forward to management for resolution.

  • 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.

REQUIREMENTS:

  • Associates 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.

  • Accurate and high volume data entry with the ability to enter directly into the system.

  • Salary-$24.00 per hour

Why Kelly ® ?

You’re looking to keep your career moving onward and upward, and we’re here to help you do just that. Our financial staffing experts will connect you with premier companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in in your career. It all adds up.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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