DO WORK THAT MATTERS
At Abbott, diverse ideas, perspectives, and expertise allow us to create 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 an International Regulatory Affairs Specialist within our Abbott Rapid Diagnostics business located in Scarborough, ME. In this role, you will perform a variety of functions in support of international product registrations for new and modified products.
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.
- Compiles and publishes all material required for submissions, license renewals, and annual registrations.
- Assists in the research of scientific and regulatory information in order to write submission documents.
- Maintains approvals/licenses/authorizations for existing marketing authorizations.
- Ensures compliant shipment of products through the maintenance of applicable inclusions, spreadsheets, etc.
- Adds and maintains the information contained in the Global Regulatory Information Database.
- Assesses product, manufacturing and labeling changes for regulatory reporting impact and compliance to regulations.
- Carries out duties in compliance with established business policies.
- Demonstrates commitment to the development, implementation, and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies.
- Bachelor’s degree (BS/BA) in any biological science or equivalent combination of education and experience
- Zero to five years’ experience in Regulatory Affairs or a related field such as Quality
- Basic to good knowledge of federal regulations
- Demonstrated written and verbal communication skills
- Strong time management skills, with the 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
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.
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.