Mdr Project Manager / Project Manager I

Mdr Project Manager / Project Manager I


Mdr Project Manager / Project Manager I

Details of the offer

Title: MDR Project Manager
Location: Saint Paul, MN
Job Duties: List the significant/essential duties, tasks or responsibilities which employees in this position are
required to perform.
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
Performs other related duties and responsibilities, on occasion, as assigned.
Qualifications: Describe the minimum education and experience, including knowledge, skills and abilities,
required to successfully perform the job. List any certificates, license, and/or registrations required.
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
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%
MDR Project Manager, Regulatory Affairs
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

Disha Kakkad
Talent Acquisition Specialist
Experis CORE
Desk # - 414-203-8334 Extn: 7124
100 Manpower Place, Milwaukee WI 53212

Experis is an Equal Opportunity Employer (EOE/AA)

Source: Dice



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