Project Manager # JN -052021-64085

Plymouth, Minnesota
Industry: Business Analyst / Project Manager
Job Number: JN -052021-64085

Title: Project Manager

Location: Plymouth, MN

Duration: 12 Months Contract

 

Required Qualification/ Experience:

  • Need Strong PM exp with certifications
  • Good analytical skills as they will be dealing with Data and Excel
  • Good communication , Time management
  • Medical dev is preferred. Any regulatory is ok
  • SAP exp is required and Windchill is preferred
  • Education – bachelors or an equivalent PM management education
  • Onsite – full time onsite initially and then rotational
  • SAP exp is required and Windchill is preferred

 

Key Responsibilities:

  • Project manage deliverables per project plans.
  • Create and manage labeling and UDI change processes within the document management systems.
  • Create and modify product labels or other labeling materials ensuring compliance to all regulatory, legal, and medical requirements following the established design format, labeling style, and branding guidelines.
  • Work cross-functionally to identify and resolve labeling and UDI inconsistencies to meet applicable requirements and project timelines.
  • Facilitates end-user training and assists in identifying resolution business and technical problems.
  • Performs analysis and audits of UDI & or Labeling data to support regulatory compliance and cross-functional business requirements.
  • Manage Labeling and UDI master data and workflow via internal IT systems.
  • Manages concurrent deadlines and meets deadlines for assigned work/tasks.
  • Analyze and interpret large data sets and identify methods of resolution.
  • Complies to world-wide Labeling and UDI regulations and cross-functional business requirements.
  • Comply with company initiatives in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), FDA & world-wide regulations, business requirements, company policies and operating procedures.

 

Qualifications:

  • BA or BS degree in communications, regulatory, business, mathematics or equivalent combination of education and work experience.
  • Project Management certification or coursework preferred.
  • Ability to manage projects and drive them to completion with attention to detail.
  • Requires ability to be innovative, resourceful, and work with minimal direction.
  • Knowledge of FDA & EU regulations, GS1 and ISO standards.
  • Strong written and verbal communication, at all organizational levels.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Experience working in medical device industry with focuses on regulatory compliance, quality systems, labeling, or UDI preferred.
  • Experience working with ERP and/or PLM systems preferred. Preferably SAP and/or Windchill.
  • Database management and/or analytics software knowledge preferred.
  • Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy.
  • Skilled in Microsoft Office specifically Excel, PowerPoint, Word, and Access.

 


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