Regulatory Affairs Specialist 1

Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management Systems per ISO, FDA, and other regulatory agencies. Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.

South Portland ME
Regulatory Specialist I
12 + MONths contract 

(1st shift) 8am - 4:30pm

Description:

Position Title Regulatory Affairs Specialist I ARDx Business Unit/Function Infectious Disease
Department Regulatory Affairs
Direct Manager Manager, Regulatory Affairs or VP, Regulatory Affairs
Primary Location (Supporting Locations) Scarborough, Maine, South Portland, Maine
Abbott Rapid Diagnostics 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.
The position of Regulatory Affairs Specialist I is within our Infectious Disease business unit 
located at Scarborough, Maine. In this role you will with general guidance, perform a variety of 
functions in support of domestic and international product registrations for new and modified 
products. 
This job description will be reviewed periodically and is subject to change by management.
RESPONSIBILITIES: 
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 Abbott Quality Management Systems 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.
BASIC QUALIFICATIONS | EDUCATION:
Bachelor’s Degree in Biology, Chemistry, Biochemistry, Engineering or other related 
technical field or the equivalent combination of education and experience. 
COMPETENCIES:
Knowledge of Federal Regulations
Demonstrated written and verbal communication skills
Strong time management skills, with the ability to work on multiple projects 
simultaneously
Ability to work independently as well as within a team
Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio
Abbott Quality Management System per ISO, FDA, and other regulatory agencies.

Exempt/Non Exempt: Non Exempt. Years Experience: 0-2 years regulatory experience and/or relevant industrial experience typically with a quality, product-development/support, or scientific affairs function Skills: Knowledge of regulations and standards affecting IVDs and/or biologics Education: BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.Duties: Responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing/operations day to day activities for change control. Provides consultation/advice to regulatory specialist for change control and product development. Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams. Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. Handles regulatory activities involved in documentation,labeling,field support. Applies regulatory and technical knowledge to a wide variety of complex work assignments. Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports. Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

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