Position       : European Medical Device Regulation (Must Have Project management Exp)

Location : Franklin Lakes, NJ

Duration : 12 Months Contract

Total Hours/week :40.00

1^st shift

Summary:

• 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
• Project management experience
• Experience in developing project plans
• Experience in project trackers management