Senior Regulatory Affairs Specialist

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

This position works out of the office of our Lake Forest, IL location in the Infectious Diseases Business Unit of Abbott Diagnostics. Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology.

What You’ll Work On

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. The individual may assist in identifying data needed, obtaining 
these 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.

In addition, If hired, you will also perform these essential job duties:

 • Strategic Planning: Assist in SOP development and review. Provide regulatory input to product lifecycle planning. Continue 
to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions. 
Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
 • Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in 
order to assess regulatory implications for approval. Determine trade issues to anticipate regulatory obstacles. Determine 
and communicate submission and approval requirements. Participate in risk-benefit analysis for regulatory compliance.
 • Premarket: Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Compile, 
prepare, review and submit regulatory submission to authorities.
 • Monitor impact of changing regulations on submission strategies. Monitor applications under regulatory review. Monitor and 
submit applicable reports to regulatory authorities. Evaluate proposed preclinical, clinical and manufacturing changes for 
regulatory filing strategies. Negotiate and interact with regulatory authorities during the development and review process 
to ensure submission approval.
 • Post market: Maintain annual licenses, registrations, listings and patent information. Assist compliance with product 
post marketing approval requirements.
 • Review and approve advertising and promotional items to ensure regulatory compliance. Assess external communications 
relative to regulations. Review regulatory aspects of contracts. Assist with label development and review for compliance 
before release.
 • Submit and review change controls to determine the level of change and consequent submission requirements. Analyze the 
input of cumulative product changes to current product submissions.
 • Contribute to the development and functioning of the crisis/ issue management program. Ensure