Associate Director, Regulatory Affairs

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 our Lake Forest IL location in the Core Diagnostics Division.

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.

Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is 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.

What You’ll Work On

MAIN PURPOSE OF ROLE

This position has primary management responsibility, directly or through lower management levels, for the preparation and submission of product approval applications. It involves working with regulatory agencies to obtain timely approvals for all products. The role also includes recommending, interpreting, and implementing company-wide policies and procedures to accomplish assignments and resolve a broad range of issues and problems. Ensuring employee compliance with these policies, practices, and procedures, and driving continuous process improvement are key responsibilities. The role assures that the quality of services meets internal and external customer requirements.

MAIN RESPONSIBILITIES

• Set strategy and direct the preparation of submissions for products to regulatory agencies, interfacing with agencies to obtain timely approval to produce and market new products.
• Provide guidance on regulatory requirements and strategies to product development project teams.
• Maintain expert working knowledge of laws, regulations, and enforcement decisions related to Quality Assurance (QA), manufacturing, and Research & Development (R&D) issues that may impact company operations and decision-making; communicate such knowledge to all internal stakeholders.
• Consult with and provide advice to senior management on strategies and plans for regulatory product approvals.
• Direct staff in implementing regulatory strategy and preparing regulatory submissions.
• Stay current on developments in fields of expertise, regulatory requirements, and industry trends; train staff on changing regulations that affect regulatory submissions. Maintain knowledge of current and pending regulations through literature, trade journals, professional associations, and conferences.
• Resolve and/or facilitate the resolution of problems, including identifying causes to prevent re-occurrence.
• Perform related functions and responsibilities, as assigned.
• Hire and retain a diverse, highly qualified staff and provide ongoing performance feedback. Maintain a safe and professional work environment.
• Support all company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with U.S. Food and D