Position Title: Regulatory Affairs Specialist I, Labeling
Location: Pomona, CA or San Diego, CA
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 Abbott Rapid Diagnostics business located in Pomona, CA or San Diego, Ca. In this role, you will be a part of the Post Market - Sustaining group within the Toxicology Regulatory Affairs Department in North America. This role creates 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.
- 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
- Assists in the maintenance of Labeling standard operating procedures, desktop instructions, templates and forms
- Assists with investigations and executes corrective actions for Quality Incidents (QIs) and Corrective and Preventive Actions (CAPAs) affecting product labeling
- Bachelor's Degree (BS/BA) in a scientific discipline
- 1-2 or more years of experience in Regulatory Affairs or related field (Clinical Affairs, R&D, Legal, or Quality Assurance)
- 1-2 or more 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
- 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
- Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio
- Proficient with graphics design software
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to