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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

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’ll 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 Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s 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

This Regulatory Affairs Specialist III position will work on-site from our Austin, TX or the Buffalo Grove, IL facility. The individual will apply foundational regulatory knowledge to provide regulatory direction to cross functional project teams. This role is responsible for preparing U.S. regulatory submissions, supporting registration with international affiliates and government agencies worldwide, and supporting manufacturing and design change management activities. This individual contributor will apply regulatory and technical knowledge to a focused area of work. This new hire will understand, implement, and maintain the quality policy, along with ensuring compliance to and demonstrating knowledge of site and division level policies and procedures.

What You’ll Work On

• Utilizes foundational understanding of laws and regulations to guide business decisions.

•  Coordinates with team to execute regulatory strategy in relation to product development/maintenance, regulatory submissions, and project plans.

•  Analyzes the regulatory impact of cumulative product changes to existing product submissions.

•  Shares knowledge with others in department and on cross functional teams.

•  Provides solutions to a variety of problems where analysis requires moderate degree of evaluation.

•  Establishes plans and executes against project goals.

•  Prepares written documentation in a clear and concise fashion, appropriately designed for varying target audiences.

•  Responsible for implementing and maintaining the effectiveness of the quality system.

•  Official correspondence with outside regulatory agencies in coordination with team members.

•  Conducts basic negotiations on routine product related issues with government agencies as appropriate.

•  Follows through on submission related activities to secure product approval/clearance for new product introduction or changes to existing product.

•  Directs own daily activities by utilizing team goals and division regulatory priorities.

•  Provides support to Regulatory Affairs management when working towards resolution of compliance issues assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system.

•  Executes Division Regulatory Strategy in functional work areas.

Required Qualifications

• Bachelor's Degree preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc

• Minimum of 5 years of experience

Preferred Qualifications

• Medical Device experience preferred

• Desire 1-2 years of regulatory experience

• RAPS Certification preferred  

Apply Now

* 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:  www.abbottbenefits.com

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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

     

The base pay for this position is

$64,000.00 – $128,000.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

ADC Diabetes Care

        

LOCATION:

United States > Texas > Austin : 12501B Research Boulevard

     

ADDITIONAL LOCATIONS:

United States > Flex Buffalo Grove : 700 Corporate Grove

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

     

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf