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EU MDR Project Manager - Medical Device
Project Manager
Andover, MA

In this role, you have the opportunity to
Lead the Radiology Informatics (RI) business implement European MDR regulations. Preparing the business for the changes as required by the EU MDR and supporting the RI input into the Healthcare Informatics business group Quality Management System

You are responsible for
*Setting up and driving our MDR Readiness Project including developing the project charter with associated milestones. MDR Readiness is one of the main topics on the Radiology Informatics Management Team agenda and we have an ambitious project in place. We are seeking for a top-tier professional that will lead this very important project that covers product development aspects, introduction of new processes, complaint solutions that work for the business, as well as ad-hoc project management in case of potential difficulties. In order to be successful, you will have to work with many stakeholders across functions, locations, and cultures on a variety of interesting and challenging topics.
*Setting-up & driving our Unique Device Identification (UDI) Project. Similar to the MDR Readiness Project we are currently setting up a Project for implementation of UDI related topics. Significant work has taken place at the business group level and continuation is needed at the RI level. Initially you will be responsible for setting-up & structuring this project and subsequently you will own & drive it to successful implementation.

You are a part of
You will be working in Radiology Informatics (part of the Healthcare Informatics Business Group) in our Quality and Regulatory group. We are a small team of professionals that are passionate about improving people’s lives and have broad responsibility for realizing business strategy, objectives, and operating plan for Radiology IT. The team is based across multiple locations in Pleasanton, Bangalore, Eindhoven and Haifa. You will be working with team members who are based in these locations.

To succeed in this role, you should have the following skills and experience
• A Bachelor’s Degree preferably in sciences
• 5+ years of work experience in the Medical Device industry
• Demonstrated Project/Project management experience
• Several years of project management and stakeholder management experience
• A background in one or more of the following disciplines Quality &Regulatory, Audit, Regulated industries is preferred; however candidates that don’t have this background but are eager to learn & invest are also considered
• Knowledge and/or experience of software development is a preferred however not a pre-requisite
• Excellent communicator, able to accurately and succinctly communicate project and business status to a variety of different stakeholders
• Looking for a curious and flexible self-starter that can initiate and drive improvements and pro-actively bring forward ideas for change
• We are seeking an ambitious colleague that is willing to invest in him/herself and Radiology Informatics. The role has high exposure across all disciplines within Radiology Informatics.
• Fluent in English
**PMP preferred


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