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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.

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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communication.

Required Qualifications

• Bachelor's Degree in a technical discipline preferred, or an equivalent combination of education and work experience.

• Minimum 10 years of progressive work experience in regulatory affairs or a related discipline in the in vitro diagnostics/medical device field.

Preferred Qualifications

• Maste r’s or Doctorate Degree preferred. An advanced credential in a relevant discipline/concentration is advantageous.

• Prior experience in medical devices and thorough knowledge of clinical research and/or regulatory affairs preferred. Academic or in-house courses in leadership, training, Continuous Improvement (CI), cycle time improvement, etc., are preferred. RAPS certification is advantageous.

• Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment.

• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.

• Ability to work effectively within a team in a fast-paced changing environment. Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization.

• Ability to multi-task, prioritize, and meet deadlines in a timely manner.

• Ability to plan strategically and work independently. Strong organizational, planning, and follow-up skills, and the ability to hold others accountable.

Apply Now (https://www.jobs.abbott/us/en)

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

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 $125,300.00 – $250,700.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com