• Us Citizen

• Green Card

• Corp-Corp

• Consulting/Contract

• UG :- - Not Required

• PG :- - Not Required

• No of position :- ( 1 )

• Post :- 19th Jun 2021

• 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.