Program Manager Mdr

Bd Medical

Dublin South

As a result of new Medical Device Regulation legislation in the EU, technical files for existing BD products will need to be remediated and brought up to the new standard. The new Project manager will provide significant cross functional co-ordination and accurate execution of a multi year multi million dollar program to ensure BD products are maintained on the market providing life sustaining performance. Job Purpose: The EU’s newMedical Devices Regulation (MDR) was published in 2017. The new rules will come into full application in 2020. Medical devices that BD supply to the European market will need to meet these new regulations in order to maintain CE marking for all medical devices and ensure continued business within both the EU and global markets that leverage the CE marking for registration. The MDR Program Manager (PM) is a critical position responsible for planning and execution of all activities associated with Product and documentation readiness activities for Product Registration within the Diabetes Care (DC) Business Unit as part of the wider BD wide Implementation of the MDR. Responsibilities: The PM will prepare execution strategies and project plans for the implementation of the MDR within the DC Business Unit, and coordinate the alignment and execution of all activities related building the new Technical Documentation and obtaining CE marking in compliance with EU MDR. With expertise in Project Management, this individual will proactively coordinate cross-functional deliverables from R&D, Regulatory, Medical Affairs, Quality, Biocompatibility and any other functions as needed to deliver the new Technical Documentation and apply for CE Marking. In all actions, the Program Manager must demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policies and all other documented quality processes and procedures. In addition the Program Manager must: Develop and maintain constructive and cooperative working relationships with various functions in the organization. Develop plans using goals and objectives of the project, appropriate related procedures, applicable historical information, and other necessary resources to align projects with the expectations of sponsors and stakeholders. Establish and lead Project teams to identify and deliver all required Project activities. Achieve delivery of Project scope, schedule, and budget requirements. Ensure project plan and schedule are created and maintained. Ensure all interdependencies are captured and accounted for in the overall schedule and resource model. Execute project plans (quality, risk, communication, resources, development, etc.) to achieve on-time project delivery performance objectives. Measure performance and progress of all assigned projects using appropriate tools and techniques. Manage and control changes to the project scope, project schedule, project resources, and project costs to keep the project plan accurate, updated, and reflective of authorized scope, budget and schedule. Monitor resource loading using appropriate and available tools. Recommend and facilitate sharing of resources among constituent projects to the overall benefit of the organization. Lead and facilitate stakeholder management by communicating relevant information regarding project decisions and prioritizations. Provide performance feedback on assigned project team members to functional management. Identify and facilitate continuous improvement activities. Skills profile. Able to Deliver results by inspiring and mobilizing people and teams. Strong ability to network and collaborate effectively with leadership teams. Ability to accurately assesses and escalate issues and resource needs. Conveys clear goals and expectations. Dynamic problem solver able to anticipate potential problems and create solutions. Ability to run meetings and workshops (face to face, conference call, Global Connect. Drives for results and success delivering end results. Well organized team player, experienced in working within global virtual teams made up of different cultures. Extensive Experience of successfully managing complex, cross functional projects is preferred. This position Dun Laoghaire, Ireland and can require up to 20% of international travel. Qualificiations. Engineering Degree qualification, further education in project management a plus. Post-graduate qualification in project management a distinct advantage. Minimum of 8 years related business experience required. About Us. BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health. This job originally appeared on RecruitIreland.com.

2194 days ago