Senior Regulatory Affairs Specialist
Abbott
United States > Itasca - AMDC : 1015 West Devon Ave, Unknown
Full-Time
$78,000
OfficeSenior
Senior Regulatory Affairs Specialist
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 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 works out of our Itasca or Chicago, IL (Willis Towers) location in the Abbott Molecular Division. 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 an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. This role is part of the on‑market regulatory team and includes responsibility for performing regulatory impact assessments for changes related to marketed products. The individual may assist in identifying data needed, obtaining data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.
What You’ll Work On
Interpret and apply regulatory requirements.
Perform regulatory impact assessments to evaluate changes for on‑market products.
Compile, prepare, review, and submit regulatory submissions to authorities.
Regulatory history, guidelines, policies, standards, practices, requirements, and precedents.
Regulatory agency structure, processes, and key personnel.
Principles and requirements of applicable product laws.
Submission/registration types and requirements.
Principles and requirements of promotion, advertising, and labeling.
Domestic and international regulatory guidelines, policies, and regulations.
Ethical guidelines of the regulatory profession, clinical research, and regulatory process.
Required Qualifications
Bachelor’s degree (or equivalent); bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
Regulatory experience or relevant industrial experience typically with a quality; product development/ support, scientific affairs function.
Preferred Qualifications
Two to Three years of experience in regulatory preferred.
Three to four years’ experience in a regulated industry (e.g., medical products, nutrition
Masters degree in Regulatory Affairs may be used in lieu of direct regulatory experience.
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next 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.
The base pay for this position is
$78,000.00 – $156,000.00In specific locations, the pay range may vary from the range posted.