Regulatory Affairs Specialist II
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 II, LABELING within our Abbott Rapid Diagnostics business located at POMONA, CA. In this role, you will create direct product labeling using specialized software and Microsoft Office applications, route labeling in the change management system, and interface 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
- Works with Engineering and Process Improvement departments to determine label specifications and obtain labeling proofs
- Works 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
- 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.
- Two to five years of experience in Regulatory Affairs or related field (Clinical Affairs, R&D, Legal, or Quality Assurance).
- Prior experience creating and/or approving medical device or IVD product labeling.
- One to two years in an IVD or medical device manufacturing environment.
- Good knowledge of federal and international regulations.
- Good knowledge of quality systems in a regulated manufacturing environment.
- 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.
- Drives for results
Job posted: 2020-09-27