Job Description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Senior Regulatory Affairs Specialist

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You\xe2\x80\x99ll also have access to:

Career development with an international company where you can grow the career you dream of.

Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

An excellent retirement savings plan with high employer contribution

Tuition reimbursement, the student debt program and education benefit - an affordable and convenient path to getting a bachelor\xe2\x80\x99s degree.

A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The position of Senior Regulatory Affairs Specialist is within our Toxicology Business Unit located in Lake Forest, IL. This role is responsible for directing and coordinating the implementation of regulatory compliance programs as required by federal, state, and local government agencies. This includes achieving government registration and licensure approval of new products and assuring that current products and manufacturing operations are in compliance with applicable regulations. You will interact with Marketing, Sales Regional Regulatory Affairs staff, regional distributors, governmental regulatory agencies and other third-party accrediting bodies.

This job description will be reviewed periodically and is subject to change by management.

What You\xe2\x80\x99ll Work On

Provides regulatory support for commercial diagnostic products

Develops regulatory strategies to achieve clearance/approval internationally (outside United States)

Compiles and publishes all material required for submissions, license renewals, and annual registrations

Works with governmental regulatory agencies and other third-party accrediting bodies

Maintains approvals/licenses/authorizations for existing marketing authorizations

Adds and maintains information contained in the Global Regulatory Information Database

Provides recommendations on labeling, for regulatory compliance

Develops internal procedures and tools

Conducts informational or training sessions for stakeholders

Organizes and maintains hard copy and electronic department files

Keeps informed of global regulatory information

Carries out duties in compliance with established business policies

Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company\xe2\x80\x99s policies and practices.

Demonstrates commitment to the development, implementation and effectiveness of Company Quality Management System per ISO, FDA, and other regulatory agencies.

Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

Performs other duties and projects as assigned

Required Qualification

Bachelor\xe2\x80\x99s degree (BS/BA) in a scientific field

3-5 years of experience in a regulated industry

Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio

Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor

Must be detail-orientated, self-motivated and available for flexible scheduling

Strong written and verbal communication, problem solving and motivational skills

Preferred Qualification

3 years of experience in Regulatory Affairs

Three plus years in an IVD or medical device manufacturing environment

510k submission experience

Technical file creation and maintenance experience

Strong knowledge of US and Foreign regulations

Able to work on multiple tasks simultaneously as a team member and/or ability to operate as an individual contributor

Possess a high degree of accuracy, detail-orientated, self-motivated and available for flexible scheduling

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at , on Facebook at and on Twitter @AbbottNews.

The base pay for this position is $71,300.00 \xe2\x80\x93 $142,700.00. In specific locations, the pay range may vary from the range posted.

Abbott