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Abbott MDR Project Manager in Plymouth, Minnesota

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 103,000 colleagues serve people in more than 160 countries.

Job Duties:

  • 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.

Qualifications:

  • BA or BS degree (degree in a technical discipline highly preferred).

  • A minimum of 5 years of technical experience, including at least 4 years of regulatory experience in a medical device industry.

  • Experience working in a broader enterprise/cross-division business unit model preferred.

  • Experience with 510(k) applications, PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions.

  • Ability to work in a highly matrixed and geographically-diverse business environment.

  • Ability to leverage and/or engage others to accomplish projects.

  • 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 communications with ability to effectively communicate at multiple levels in the organization.

  • Multi-tasks, prioritizes and meets deadlines in timely manner.

  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.

  • Ability to travel up to approximately 15%

Specific Qualifications

PMBOK Core Competencies

  • Project Integration

  • Project Planning

  • Project Scope Management

  • Project Time Management

  • Project Cost Management

  • Project Resource Management

  • Project Risk Management

  • Project Communication Management

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

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