Sr. Regulatory Affairs Manager

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 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

The Sr. Regulatory Affairs Manager hired in this role will work out of the Lake Forest, IL location 4-5 days a week in the office. This role will require some travel up to 25% to Abbott locations potentially in and outside of the US. This is part of the Infectious Diseases Division at Abbott Rapid Diagnostics. This role reports to the leader that also leads Global New Product Introductions and US Regulatory. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

What you will do

Provide regulatory affairs project management for various areas, to include 510(k), CLIA Waiver, label/advertising/promotional review, and other regulatory compliance activities. In collaboration with the Regulatory leadership, develop and implement regulatory strategies that will ensure earliest possible introduction of product(s) into domestic and international markets. 

In addition, the person hired will:

• Coordinate preparation of well organized, complete and scientifically sound regulatory submissions. 

• Interface directly with various regulatory agencies, as required, to facilitate the review and approval of regulatory applications.   

• Exercise judgement within generally defined practices and departmental standard operating procedures. 

• Develop and maintain strong and effective relations with internal/external personnel.

• Interacts with regulatory agency to expedite approval of pending registration.

• Serves as regulatory liaison throughout product lifecycle.

• Participates in some of the following: product plan development and implementation, regulatory strategy, risk management.

• Serves as regulatory representative to marketing, research teams and regulatory agencies.

• Advises development and/or marketing teams on manufacturing changes, technical labeling, appropriate regulations and interpretations.

• Keep abreast of regulatory requirements in the US and countries where the Division intends to offer product for sale.

• Work with the Regulatory leadership to prepare regulatory plan/strategy for product introductions.

• Manage the preparation of registration documents as required for international markets.

• Ensure that submissions are complete, properly formatted, and comply with applicable regulatory requirements.

• Make certain that appropriate documentation is maintained to record regulatory decisions made in design and development activities.

Minimum Qualifications:

• Bachelor's Degree Preferably in scientific or engineering related disciplines or an equivalent combination of education and work experience

• At least 6 years or more of experience in a similar role in similar organization.

Preferred Qualifications

• Advanced degree or additional professional training in regulatory affairs (RA) desired.

• At least 3 years of experience with molecular and lateral flow assays

• Must have well developed written, oral, interpersonal and negotiation skills.

• Leadership competency including organizational development and project management skills.

The base pay for this position is

$111,300.00 – $222,700.00

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

     

JOB FAMILY:

Regulatory Operations

DIVISION:

ID Infectious Disease

LOCATION:

United States > Lake Forest : J55

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 25 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment, Keyboard use (greater or equal to 50% of the workday)

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