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Project Manager
Plymouth, Minnesota
Contract Position
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Applied on June 21, 2021
Job Id #47625 Posted May 13, 2021


JOB DESCRIPTION

  • The Labeling Systems and Data Project Manager will be responsible for meeting business needs by supporting the Labeling and Unique Device Identification (UDI) teams by leading/implementing projects, conducting analysis, developing managing master data, communicating with cross functional teams, and problem-solving various challenges. 

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.

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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EQUAL OPPORTUNITY EMPLOYMENT SURVEY

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

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