Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist

Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity
This position is based at the Abbott Park, IL (Lake Bluff, IL) or Willis Tower, IL (Chicago, IL) location within the Transfusion Medicine business. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

As the Principal Regulatory Affairs Specialist, you’ll be an individual contributor, combing knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured, or distributed to meet required legislation. The individual has department level influence and is generally recognized as an expert resource within the department. The individual shares knowledge and expertise with others in support of team activities. The individual helps identify, obtain, and effectively present data for the registration of products worldwide.– CAN Modify

What You’ll Work On

• Knowledge base includes: domestic and international regulatory policies/requirements, submissions/registration types, and advertising and labeling promotional requirements

• Interprets and implements regulatory requirements

• Defines regulatory strategies and performs regulatory assessments

• Exercises sound and ethical judgment

• Compiles, prepares, reviews, and submits regulatory submissions to authorities

• Negotiates internally and externally with regulatory agencies

• Effectively communicates verbally and in writing with diverse audiences and personnel

• Writes and edits technical documents

• Clear articulates plans/strategies regarding significant matters with managers and directors, often requiring the coordination of activities across business units

• Participates in the development of others by facilitating training and providing feedback and guidance

• Creates and executes project plans and timelines

• Organizes and tracks complex information

• Thinks both analytically and critically

• Works with cross-functional teams from various disciplines and cultures

• May lead a cross-functional project team

• Has broad knowledge of various technical alternatives and their potential impact on the business

• Provides technical leadership to business units

• Follows scientific arguments, identifies regulatory scientific data needs, and solves regulatory issues

• Uses in-depth knowledge of business units and cross group dependencies/ relationships

Required Qualifications

• Bachelors Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications).

• Experienced in domestic and international regulatory submissions for biologics or in vitro diagnostic (IVDs). Experienced in working within the requirements of 21 CFR 600 and/or IVDR EU 2017/746.

Preferred Qualifications

• 2 to 5 years of experience in regulatory preferred; may consider quality assurance or related functional area

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://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 abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers