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Regulatory Affairs Specialist at Alere

Posted in Compliance 30+ days ago.

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Type: Full Time
Location: Scarborough, Maine

Job Description:


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 TRANSFER SCIENTIST within our Abbott Rapid Diagnostics business located in SCARBOROUGH, ME. In this role, you will ensure compliance with applicable regulatory requirements.

Abbott Rapid Diagnostics (formerly Alere) is part of Abbotts 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

With general guidance, performs a variety of functions in support of domestic and international product registrations for new and modified products.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

* 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 information contained in the Global Regulatory Information Database.

* Assesses product, manufacturing and labeling changes for regulatory reporting impact and compliance to regulations.

* Organizes and maintains hard copy and electronic department files.

* Keeps informed of global regulatory information.

* Assists in developing internal procedures and tools.

* 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.

* Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companys policies and practices.

* Performs other duties and projects as assigned.


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


* Bachelors degree (BS/BA) in any biological science.

* Zero to five years experience in Regulatory Affairs or 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


* The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

* The noise level in the work environment is usually quiet.


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.