AbbVie

*Sr Device Tracking Coordinator

Employer
AbbVie
Location
Austin, TX, United States
Posted
Sep 23, 2020
Ref
202094
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
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 .

Job Description

Under general direction, the Senior Device Tracking Coordinator will coordinate device tracking activities by ensuring device tracking files are maintained, reconciling device tracking data, follow-up for device tracking forms/data is in compliance with regulations established by the FDA and international regulatory bodies, and submit notification reports to the FDA and international Competent Authorities.

He/she will facilitate actions identified to improve customer experience and patient safety, participate and/or lead in the identification and implementation of device tracking management system improvements, including technical support, 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. Provides technical and administrative support to internal and external customers. Works with little to no supervision.

Qualifications

Essential Skills:
  • 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 functions in a controlled environment by the FDA and other regulatory authorities.
  • Must have effective written/oral, interpersonal, 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).
  • Knowledge of Device Tracking / Product Surveillance / Complaint Investigation experience is preferred.


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.