VIVA USA Inc Project Leader in Deerfield, Illinois
Req Ref No: SGILPL20 Location: Deerfield , IL Duration: 12 months
This Project Leader I will work under R&D leadership to lead the EU MDR remediation project(s) for the Advanced Surgery Global Business Unit product portfolio to support EU registrations through the relevant notified bodies for maintenance and MDR submissions.
Create and maintain remediation project schedules Identify resources needed and secure resource allocation, with leadership help, as needed Lead remediation team meetings, maintain risks and issues list(s) Recognize issues and develop solutions with the team to keep project(s) on track Support preparation for meetings with stakeholders to report status and present issues for decision-making Own the labeling remediation process Support the cross-functional content review of the clinical evaluation related deliverables
Experiences coordinating medical device projects working cross-functionally with contributing disciplines Understands key processes, including product development documentation, change control, labeling, clinical evaluation and post-market surveillance Able to organize across multiple initiatives and integrate work streams into a cohesive project Communicates effectively with team and stakeholders with appropriate levels of detail and escalates effectively, when needed
Minimum of a completed Bachelors of Science focused in (discipline Engineering or Science discipline.) Software skills: Excel and MS Project; also, Word, PowerPoint, SharePoint, One Drive, Outlook Medical Device industry experience required Must have experience with multiple projects in parallel Previous remediation experience
Medical Device industry (Surgical Tools, ideally) experience required PM from medical device background with the ability to work on multiple projects in parallel Previous MDR experience would be ideal Bachelors of Science focused in Engineering, Science discipline. Software skills: Excel and MS Project; also, Word, PowerPoint, SharePoint, One Drive, Outlook
Remotes during COVID. onsite expected after COVID. Medical Device background strongly preferred for this role; this is not a regulatory related role.
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.