at Abbott in Lake Forest, Illinois, United States
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.
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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
The position of Regulatory Affairs Specialist II is within our Toxicology business unit located in Lake Forest, IL. In this role, you will work as part of the Regulatory Affairs department with direct responsibility for the preparation of documentation for domestic and international product registrations for new and modified products, regulatory assessment of product changes, review and approval of labeling and advertising/promotional materials, approval of global product distribution, and maintenance of regulatory records and files.
What You’ll Work On
+ Provides extended regulatory support for diagnostic product development and commercial diagnostic products
+ Assists in developing regulatory strategies for products in development and for modified products to achieve clearance/approval in the US and internationally
+ Researches scientific and regulatory information in order to write submission documents
+ Maintains approvals/licenses/authorizations for existing marketing authorizations
+ Adds and maintains information contained in the Global Regulator1Information Database
+ Assesses product, manufacturing and labeling changes for regulatory reporting impact and compliance to regulations
+ Compiles and publishes all materials required for submissions, license renewals, and regulations
+ 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.
+ Demonstrates commitment to the development, implementation and effectiveness of Company Quality Management System 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.
+ 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.
Required Qualifications
+ Bachelor’s degree (BS/BA) in any scientific field
+ 2-3 years’ experience in Regulatory Affairs
+ Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio
+ Must be detail-orientated, self-motivated and available for flexible scheduling
+ Strong communication, problem solving and motivational skills
+ Demonstrated written and verbal communication skills
Preferred Qualifications
+ One to three years in an IVD or medical device manufacturing environment
+ Good knowledge of federal regulations, product labeling and related requirements, quality systems in a regulated manufacturing environment
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
+ Training and career development , with onboarding programs for new employees and tuition assistance
+ Financial security through competitive compensation, incentives and retirement plans
+ Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
+ Paid time off
+ 401(k) retirement savings with a generous company match
+ The stability of a company with a record of strong financial performance and history of being actively involved in local communities
- 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 (http://www.abbottbenefits.com/pages/candidate.aspx)
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 $56,700.00 – $113,300.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
