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, 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.
- 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!