Abbott

Regulatory Affairs Specialist

Abbott

Abbott Labs J46, 1850 Norman Dr N, Waukegan, IL 60085, USA
Full-TimeDepends on ExperienceMid-LevelBachelors
Job Description

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.

Where is this job?
This job is located at Abbott Labs J46, 1850 Norman Dr N, Waukegan, IL 60085, USA
Job Qualifications
  • 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

Required Skills
  • MS Visio

  • MS Project

  • MS Excel skills

  • Effective Time Management

  • Complaint handling

  • Post-market Regulatory Reporting

Soft Skills
  • Results Oriented

  • Communication Skills

  • Adaptability

  • Problem Solving Skills

  • Detail oriented and highly organized

  • Process Oriented

  • Multi tasker

Compensation

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.

Additional Information
Abbott is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedFebruary 1st, 2022
Apply BeforeJune 21st, 2025
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About Abbott

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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