Job Details

ID #15583594
State Texas
City Irving
Job type Contract
Salary USD $40 - $50 40 - 50
Source Technosoft Corporation
Showed 2021-06-18
Date 2021-06-17
Deadline 2021-08-16
Category Et cetera
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Project Manager for Medical devices Labeling

Texas, Irving, 75014 Irving USA

Vacancy expired!

  • SPOC for labeling COE activities
  • Coordinate between Buyer stakeholders and SMEs.
  • Documentation and maintenance of the labeling procedures
  • Creation of Redlines, Artwork/Label design & Managing Change Orders & Vendor Follow-ups. Responsible for tracking and maintaining deliverables.
  • To monitor progress towards project goals & objectives
  • Interact with Buyer, understand their requirement & provide delivery team with Buyer expectations
  • Work closely with outside services such as translation houses, service bureaus, design houses and consultants as needed. Coordinate and lead progression meetings.
  • Work closely with project leaders on collaborating and collecting the right inputs.
  • Coordinate vendor (printers) concurrence on drawings
  • Lead and Coordinate Labeling Design Change projects.
  • Ensures all Design change activities are planned, approved and executed.
  • Coordinate various team member activities to ensure project plan targets are defined and met.
Prepare and executes a Design Change Notice to describe the proposed change, the project plan for accomplishing the design change, formal approvals and transfer checklist.
  • Prepare, execute and organize a formal "Design review meetings".
  • Prepare and execute Verification and Validation activities.
  • Prepare and present, in conjunction with appropriate team members, project status reports, revisions to project plan and issues that may affect project targets or intended product performance or characteristics.
  • Leads collaborative team meetings with cross-functional subject matter experts (SME) to arrive at a consensus for Design changes.
Prepare and maintains the Design History File (DHF) for the project.
  • Manage multiple projects using Project management tools and methods including kick-off meetings, project plan development, timeline management, risks and issue logs, mitigations, status updates, and metrics.
  • Good exposure & hands-on in Medical device labeling standards, including 21 CFR 801 – Labeling, 21 CFR 820 – Device Labeling, 21 CFR 830 – Unique Device Identification, FDA 89-4203 and ISO 15223, EU-MDR.

Vacancy expired!

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