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 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 high employer contributionTuition 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Our location at Abbott Park, IL is looking for a Regulatory Affairs Project Manager onsite within the Abbott Quality & Regulatory (AQR) team.

As an individual contributor this person will be responsible for working on compliance with emerging requirements and metrics. They will serve as a process owner for FDA site registration and device listing activities along and contribute to regulatory metrics.

The individual will exercise judgement within generally defined practices and departmental standard operating procedures and develop and maintain strong and effective relations with internal/external personnel.

What You’ll Work On

Lead or support projects related to emerging requirements for corporate led programs.Organize lead driven initiatives, work plans, and team meetings and work with AQR Leadership to manage conflicting priorities and resource limitations.  Serve as process owner for FDA site registrations and device listings along with owning the requisite process documents in the quality system.Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across business units for management review.Anticipate risks and obstacles throughout projects and develop solutions with team membersProvide proactive, diligent, and fact-based communication to Associate Director, peers, and team.Organize subject matter experts to identify, develop and implement new regulatory policies and procedures.Create and review regulatory policies and procedure documents as they apply to projects and areas of responsibility.Create and maintain existing Power BI dashboards for regulatory metrics.Complies company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

Bachelor’s Degree, preferably in Life Science, or closely related discipline.5+ years’ experience managing projects in a regulated industry, leading cross-functional and/or cross-divisional project teams.Understanding of medical device regulations (incl: device classifications and risk categorization).  Knowledgeable on Power BI and data visualization techniques.Familiar with EU MDR/IVDR, Unique Device Identifier (UDI) and FDA FURLS requirements.Professional certification (PMP or RAC) a plus.

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 and @AbbottGlobal

The base pay for this position is $97,300.00 – $194,700.00. In specific locations, the pay range may vary from the range posted.