Device Tracking Manager
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 Manager will lead device tracking activities to ensure device tracking files are maintained and reconciled. He/she will communicate with regulatory bodies in inspection settings and in written reports. 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.
- Oversee the device tracking system and process forms to support compliance with device tracking regulations and internal procedures.
- Coordinate with inter- and intra-departmental customers to ensure device tracking information and inquiries are communicated appropriately. This includes communicating with FDA when contacted.
- Coordinate department processes and workflow.
- Identify problems and potential issues.
- Perform tracking system audits, reconcile data, and identify non-compliant distributors.
- Initiate and process follow up activities to gather information, submit notifications, etc.
- Assist in resolving issues by responding to inquiries and answering technical questions regarding device tracking.
- Report non-compliant distributors to FDA.
- Lead and/or assist compliance and process improvement initiatives (e.g. validation, process assessments/improvements, product transfers, automation of system, customer service).
- Investigate CAPA / Non-Conformance investigations, perform root cause analysis, identify and implement corrective and preventive actions as necessary.
- Assist in the preparation, coordination, and execution of regulatory inspections to Canadian and US regulations, quality policies and procedures.
- Assist in other responsibilities requested by management to ensure compliance.
Skills, Knowledge and Abilities
- Ability to analyze information for device tracking requirements under 21 CFR 821 and SOR/98-282.
- Thorough 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.
- Superior written/verbal, interpersonal, and organizational skills.
- Ability to provide accurate and complete information in a prompt manner.
- Ability to initiate or suggest plans to motivate workers to achieve work goals.
- Strong analytical skills, problem solving techniques and the ability to work with mathematical concepts such as probability and statistical inference.
- 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.
- Ability to respond to common inquires or complaints from customers, regulatory agencies, or members of the business community.
Education and Experience
- Bachelor's degree or the equivalent combination of education and experience required.
- Five years previous experience in a regulated environment (i.e. medical device or pharmaceutical).
- Experience conducting a Device Tracking program is preferred.
- Previous leadership experience preferred.
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.