New Project Manager I Job in Saint Paul, MN!
Position Title: Project Manager I

Position Number: 346405

Location: Saint Paul, MN 55117

Position Type: Long Term Contract

Required Skill Set:

FDA, Medical device, Project Management, Project Plans, Quality Management

Position Description:

**C2C is not available**
**Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.**
Job Title: Project Manager I
Duration: 10/26/2020 to 04/25/2021
Location: Saint Paul, MN 55117

MDR Project Manager

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.

General 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%

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Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.)
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About Rose
  • Founded in 1993
  • 21 office locations across the U.S.
  • 130+ Customers; corporations and government agencies
  • Employee Oriented Company
  • Challenging Assignments across the U.S.
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