
Regulatory Affairs Specialist
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. Prepares and Submits Regulatory Reports for FDA and other OUS (Outside of US) Regulatory Bodies. Monitors progress of all ongoing complaint activities and MDRs to ensure the timely submissions. Assists in the preparation of regulatory body additional information requests. 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 System per ISO, FDA, and other regulatory agencies.
Ability to work independently as well as within a team
Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management System
3+ years of related experience
MS Visio
MS Project
MS Excel skills
Effective Time Management
Complaint handling
Post-market Regulatory Reporting
Results Oriented
Communication Skills
Adaptability
Problem Solving Skills
Detail oriented and highly organized
Process Oriented
Multi tasker
According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Abbott Labs J46, 1850 Norman Dr N, Waukegan, IL 60085, USA is $67,924 - $93,851. This range is based on the salary data from the Indeed.com website.
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From removing the regular pain of finger sticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s blood donations to ensure a healthy supply, our purpose is to make the world a better place by bringing life-changing health technologies to the people who need them. That’s our commitment to helping you live your best life.

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