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Regulatory Windchill Coordinator
Saint Paul, Minnesota  |  Onsite
Contract Position
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Applied on September 29, 2022
Job Id #59303 Posted September 16, 2022


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 challenges

Key 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.

Horizontal is proud to be an Equal Opportunity and Affirmative Action Employer. We seek to provide employment opportunities to talented, qualified candidates regardless of race, color, sex/gender including gender identity and/or expression, national origin, religion, sexual orientation, disability, marital status, citizen status, veteran status, or any other protected classification under federal, state or local law.

In addition, Horizontal will provide reasonable accommodations for qualified individuals with disabilities. If you need to request a reasonable accommodation in order to complete the application or interview process, please contact hr@horizontal.com.

All applicants applying must be legally authorized to work in the country of employment.

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You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Horizontal is proud to be an Equal Employment Opportunity/Affirmative Action Employer providing a drug-free workplace.

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