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Regulatory Windchill Coordinator

Company: Horizontal Talent
Location: Saint Paul
Posted on: September 21, 2022

Job Description:


  • The Electrophysiology (EP) Regulatory Product Release Authorization (PRA) Coordinator will be responsible meeting business needs by executing product releases, clearing blocked orders, communicating with cross functional teams, and problem solving various challengesKey Responsibilities:
    • Responsible for all Product Release activities in Windchill including maintaining accurate master data, ZFIN selection, EP PRA Checklists, and proper approvers for assigned regions.
    • Execute PRA deliverables to identified timelines and priorities.
    • Reporting out to management status of any high priority product release activities
    • Analyze root cause of blocked orders and implement correct solution to resolve blocked order (PRA completion, new ZFIN, etc) per assigned regions.
    • Support prioritization of product release with international regulatory specialist or product expert for region on a weekly basis
    • General support of international regulatory specialists and/or product experts regarding PRA activities
    • Communicate with customer service, regulatory affiliates, supply chain, regulatory specialists, and product experts on timelines for releasing product to assigned regions
    • Support any other assigned projects such as data clean up, quality system documentation, training, system enhancements, etc.
    • Manages concurrent deadlines and meets deadlines for assigned work/tasks.
    • 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, engineering or equivalent combination of education and work experience.
      • Ability to manage projects and drive them to completion with attention to detail.
      • Requires ability to be innovative, resourceful, and work with minimal direction.
      • 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, or quality systems preferred.
      • Experience working with ERP and/or PLM systems preferred. Preferably SAP and/or Windchill.
      • Strong problem solving 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, and Word.

Keywords: Horizontal Talent, St. Paul , Regulatory Windchill Coordinator, Other , Saint Paul, Minnesota

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