Responsibilities:

• The Project Coordinator, Shared Services acts as the project management process owner. This role focuses on process optimization and the deployment and utilization of consistent project management methodologies in support of the execution of Periodic Safety Update Reports.  

• Knowledge and access to applicable Medical Device Quality Systems to support the teams in document retrieval and routing of documents for approval.

• Provide support during audits and inspections pertaining to PSUR processes and reports.

• The Project Coordinator, Shared Services acts as the project management process owner. This role focuses on process optimization and the deployment and utilization of consistent project management methodologies in support of the execution of Periodic Safety Update Reports. 

• Knowledge and access to applicable Medical Device Quality Systems to support the teams in document retrieval and routing of documents for approval 

• Provide support during audits and inspections pertaining to PSUR processes and reports 

• Maintain and execute project management tools, such as, Microsoft projects plans, Lean Kit boards, and monitors smooth execution of project milestones and task levels. 

• Provides project management and leadership to staff 

• Actively partners with cross-functional business partners such as Medical Directors, PSUR, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the PSUR process 

• Ensures strategic plans for operating company PSUR timelines are met and practices are being consistently deployed across the global organization 

• Maintains and monitors metrics relevant to team activities such as PSURs, CERs, Safety Surveillance activities, Literature Searches, Literatures Reviews, Compliance Activities, providing visibility of issues and enable corrective and preventive action to be taken as needed 

• Collaborate and support the Leadership team through the various processes 

Skills and Qualifications: 

• Bachelor’s degree in science or above and in alignment with project / business team requirements

• Minimum of 0 to 2 years of relevant experience in identified functional domain/ business workstream