Regulatory Affairs Specialist I, Labeling

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Location :
San Diego, California

Expiry Date :
Fri, 18 Dec 2020 23:59:59 GMT

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Description :
Regulatory Affairs Specialist I, Labeling REQ NA-USA-California-Pomona DO WORK THAT MATTERS At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals. We have an exciting opportunity for a Regulatory Affairs Specialist I – Labeling within our Toxicology business unit located in Pomona, CA. This role will work as part of the Regulatory Affairs department with direct support of the labeling creation and approval process within the Post Market – Sustaining group. In this position, you will create direct product labeling using specialized software and Microsoft Office applications, routes labeling in the change management system, and interfaces with Engineering and vendors to obtain and approve labeling proofs. Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. RESPONSIBILITIES Creates and/or revises direct product labeling according to the requirements in domestic and international standards and regulations Interfaces with Engineering and Process Improvement departments to determine label specifications and obtain labeling proofs Interfaces with Marketing and Commercial teams to support customer and private label initiatives Interfaces with vendors and external graphic designers to obtain and approve artwork files and proofs Assists with review of advertising and promotional labeling to ensure compliance with product claims Participates in product development projects and post-market projects as extended team member specializing in labeling Organizes and maintains hard copy and electronic department files, as needed Adds and maintains labeling information contained in Regulatory Registration Lists and the Global Regulatory Information Database, as needed Assists in the maintenance of Labeling standard operating procedures, desktop instructions, templates and forms Carries out duties in compliance with established business policies Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices Performs other duties and projects as assigned Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities BASIC QUALIFICATIONS Bachelor’s degree (BS/BA) in a scientific or technical discipline or equivalent experience One or more years of experience in Regulatory Affairs PREFERRED QUALIFICATIONS One to two years in an IVD or medical device manufacturing environment Introductory knowledge of federal and international regulations Introductory knowledge of quality systems in a regulated manufacturing environment Good knowledge of product labeling and related requirements Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio Proficient with graphics design software Demonstrated written and verbal communication skills Ability to work on multiple projects simultaneously Possess a high degree of accuracy and attention to detail Ability to work independently, as well as within a team COMPETENCIES: Driven for results Teamwork Communication An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. About Abbott At Abbott, we’re committed to helping people live their best possible life through the power of health. For more than 125 years, we’ve brought new products and technologies to the world — in nutrition, diagnostics, medical devices and branded generic pharmaceuticals — that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to . Quality NA-USA-California-San Diego General & Administrative Full-time