28 Nov
Project Manager / Onsite Coordinator
Indiana, Warsaw , 46581 Warsaw USA

Vacancy expired!

7-10 years of Project Management experience in the Medical Domain. 3 to 5 years managing large scale design control or large remediation projects EU MDR PMP / Prince Certification is an added advantage Must to have: EU MDR Gap Ana and Remediation Understanding of ISO 14971; ISO 10993 or Clinical Adds Value: RAC Certification: Medical Devices Good To Have US and EU Submission Worldwide regulatory agencies/authorities CE Technical File / EU Technical File / Design Dossier Support EU MDR Transition activities EU MDR Gap Analysis Collateral/Product specific IEC Standards Knowledge Understand and manage project lifeycle Accountable for project results along with Delivery Manager Work with Project Sponsor and stakeholders to understand scope, goals, deliverables and schedule across multiple team members and multiple sites Understand and discuss financial aspects of the project, with customer stakeholders Collaborate with Engineering, Quality, Operations and External vendors in ensuring all the teams are aligned to project goals and track to schedule Coordinate the cross-functional discussions and assign the individual teams to actions required Clearly communicate expectations to team members Act as mediator between stakeholders and team members Resolve issues and solve problems throughout the project life cycle Effectively manage project scope, changes in scope are documented and approved Understand the Risks and help mitigate the same Understand Customer tools for Project management and metrics reporting Provide Project Status update to Stake holders Present the weekly and Bi-weekly status to senior management Discuss the deviations and changes in the trends with the schedule and the cost to the stakeholders Determine how results will be measured, and complete post-project retrospective to evaluate how well results are achieved

Vacancy expired!


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