Full Time | IT Outsourcing & Consulting3 Months Ago
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millenniumsoft is Hiring an European Medical Device Regulation (Must Have Project management Exp) Near Franklin, NJ
Position : European Medical Device Regulation (Must Have Project management Exp)Location : Franklin Lakes, NJDuration : 12 Months ContractTotal Hours/week :40.001st shiftSummary
The European Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe.
It is to have a fundamental revision in 2017 to better identify medical devices products and improve transparency through standard data, technological advances, and the establishment of an EU database (Eudamed).
Similar to the FDA’s UDI, EU MDR will establish a robust, transparent, predictable, and sustainable regulatory framework for medical devices to ensure a high level of health and safety while supporting innovation.
EU MDR is relevant to any organization producing or supplying medical device products to Europe.
As our Project Management Assistant for Operations, your job will be to support the Project Managers to ensure the manufacturing sites activities and deliverables are completed on time and produce the desired results.
Support the Operations group to ensure on-time compliance with the EU MDR requirements and maintaining minimal impact on production.
Support the communication between the Operations Project Management group and the MDS manufacturing sites.
Prepare project updates and assure that the project management tools are well used and kept updated.
Responsibilities
Support the tracking and follow up activities to ensure that all projects are delivered on-time, within the scope and budget
Support the project planning for the manufacturing sites affected by the EU MDR project
Manage the tracking tools defined for the project management
Compile data provided by the manufacturing sites
Measure project performance using the defined systems and tools
Support the creation of project updates and reports, ensuring clear and concise communication across the manufacturing sites
Create and maintain comprehensive project documentation
Desired Qualifications
BS degree in Engineering (Mechanical Engineering, Manufacturing Engineering, Materials Science & Engineering, Biomedical Engineering or a closely related engineering degree) or BS degree in Business (Supply Chain, Operations, or a closely related Business degree)
Minimum of 2 years of project management/leadership experience or equivalent is required
Medical device and process mgmt./improvement is a plus
Strong interpersonal and communication skills.
Team oriented.
Strong fit with client values
Desired Experience
Demonstrated ability to utilize MS tools to support communication and progress, Microsoft: Project, Excel, Teams, SharePoint experience is preferred