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.

Regulatory Affairs Specialist II

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 .

Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year

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

The position of Regulatory Specialist II is within our Toxicology business. In this role, you will work as part of the Regulatory Affairs department with direct responsibility for the preparation of documentation for domestic and/or 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 and commercial diagnostic products

Assists in developing regulatory strategies for products in county introduction, registration or applicable   to achieve approval  in the international countries

Researches scientific, technical  and regulatory information in order to write submission documents

Prepare and compile  all  material  required   for  submissions,   license  renewals,  no conformities  and  annual registrations

Maintains approvals/licenses/authorizations for existing marketing authorizations

Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards or other worldwide regulatory agencies to various international affiliates

Adds and maintains information contained in the Global Regulator1y Information Database

Assesses product, manufacturing and labeling changes for regulatory reporting impact and compliance to 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

Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel

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

Perform other duties & projects as assigned

Required Qualifications

Bachelor's degree (BS/BA) in any science or equivalent experience

Experience in Regulatory Affairs, Quality Affairs or life sciences with 1-2 years of progressively responsible positions

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 Qualifications

One to three years in an IVD or medical device manufacturing environment

Good knowledge of federal regulations

Good knowledge of product labeling and related requirements

Good knowledge of quality systems in a regulated manufacturing environment

SmartSheet

COMPETENCIES:

Demonstrated written and verbal communication skills

Ability to work independently as well as within a team

Ability to work on multiple projects simultaneously

Possess a high degree of accuracy and attention to detail

Teamwork

Communication

Achieving results

Apply Now

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.

The base pay for this position is $60,000.00 – $120,000.00. In specific locations, the pay range may vary from the range posted.