Regulatory Windchill Coordinator
Company: Horizontal Talent
Location: Saint Paul
Posted on: September 21, 2022
- 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
- Reporting out to management status of any high priority product
- 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
- 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,
- Manages concurrent deadlines and meets deadlines for assigned
- 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
- Ability to manage projects and drive them to completion with
attention to detail.
- Requires ability to be innovative, resourceful, and work with
- Strong written and verbal communication, at all organizational
- 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
Keywords: Horizontal Talent, St. Paul , Regulatory Windchill Coordinator, Other , Saint Paul, Minnesota
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