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Program Manager

Company: Abbott Laboratories
Location: Saint Paul
Posted on: November 18, 2021

Job Description:

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 109,000 colleagues serve people in more than 160 countries. Program Manager - MA, CA, GA, or MN ABOUT ABBOTT Leading an active lifestyle is important to the many people we serve. In Abbott's ELECTROPHYSIOLOGY & HEART FAILURE division, we're advancing the treatment of heart and vascular disease through breakthrough medical technologies in EP/HF, allowing people to restore their health and get on with their lives. WHAT YOU'LL DO We are recruiting for a Program Manager, Regulatory Affairs MDR to join our team. This position will be located in Burlington, MA, Pleasanton, CA, Atlanta, GA or in MN. In this role, you will will be responsible for planning the remediation of on-market products within the EP & HF market space. You will lead cross functional teams through planning, execution, submission to notified bodies, questions and responses, and implementation of remediated products onto the market. Projects include but are not limited to: MDR, China PTR, and UKCA Mark remediation. Responsibilities: * Manages complex device projects within the B/U. * Assures the development of multi-level project planning to achieve short and long-term business objectives * Develops, tracks and reports on all key project deliverables. * Keeps senior management team informed of progress and issues. * Develops and communicates key performance indicators (cost/schedule/technical/quality) for projects. * Ensures project teams have appropriate resources to perform assigned tasks. * Interfaces with appropriate internal and external resources to ensure intellectual property is protected. * Reviews protocols and reports to support regulatory submissions. * Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. * Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. * Performs other related duties and responsibilities, on occasion, as assigned EDUCATION AND EXPERIENCE YOU'LL BRING Required * Bachelor's degree * 8+ years of experience in a similar role within the medical device industry, including MDR and/or EU MDR submission experience * Ability to work in a highly matrixed and geographically-diverse business environment. * Demonstrated leadership skills and experience, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. * Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. * Ability to travel up to approximately 15% Preferred * Advanced level degree * Project Manager experience and/or PMP designation * Previous experience working in a broader enterprise/cross-division business unit mode * Experience with 510(k) applications, PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions. WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer: * Training and career development, with onboarding programs for new employees and tuition assistance * Financial security through competitive compensation, incentives and retirement plans * Health care and well-being programs including medical, dental, vision, wellness and occupational health programs * Paid time off * 401(k) retirement savings with a generous company match * The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully:? Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at, on Facebook at and on Twitter @AbbottNews and @AbbottGlobal

Keywords: Abbott Laboratories, St. Paul , Program Manager, Executive , Saint Paul, Minnesota

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