Medical Device Project Manager

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timePosted 11 days ago location United States salarySalary undisclosed
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Job Description

Familiarity with the FDA UDI Rule and GS1 system and data standards is going to be the key along with ISO standards. Remote but East Coast is preferred Try to keep the pay around 90hour W2 or 100 Corp Responsibilities Responsible for project planning including defining project scope, project milestones, and developing tasks with estimates author project plans that meets business objectives and complies with the quality management system Responsible for scheduling regular project status update meetings and reviews with a cross-functional project team ensures deliverable are completed and documented to meet the quality requirements following design control procedures Responsible for identifying project risks, both technical and managerial, and devise appropriate risk management plans regularly assess and report project risks to management Responsible for project execution of product development projects within FDA regulated industries while adhering to scope, schedule and budget requirements Apply best practices in initiating, planning, executing, controlling and closing processes of projects and ensure consistent practices throughout all phases of the project life cycle Use defined project management practices and procedures to identify root cause of project issues and develop a plan to resolve problems of moderate scope and complexity Facilitate cooperation of a cross-functional team consisting of RD, Usability, Clinical, Quality, Regulatory, Marketing, Operations and external stakeholders Responsible for communicating project key metrics and updates on project status (timelines, resources, and delays) to both the project team as well as management and key project stakeholders ESSENTIAL DUTIES middot Responsible for team meetings (e.g., face-to-face, teleconference, andor webinars) and generation of meeting minutes. middot Responsible for design reviews as needed. middot Responsible for communication of team objectives, charter, milestones and progress middot Owner of project status updates for Projects. middot Preparation of reports and presentations. middot Develop and track project budgets. middot Work with Finance to prepare project financial models, budget tracking spreadsheets and reports. middot Develop, assist in developing, andor execute protocols and evaluations of products affected by design changes. middot Partner in continuous improvement of Packaging and Labeling Processes and Procedures. middot Help to identify stakeholders. middot Work with all stakeholders to build consensus on areas for improvement. middot Author new or modified procedures to address opportunities for improvement. middot Manage the research, scoping and execution of the electronic management of workflow. Qualifications middot Demonstrated project management skills or certifications. middot Knowledge and understanding of FDA and ISO medical device development regulations especially as they pertain to design control and product development. middot Knowledge of corporate, division, and standard operating procedures, as they relate to Product Labeling and Sustaining Engineering. middot Knowledge of project-based product development and ability to work as a project leader. middot Excellent communication skills (written and verbal) with ability to influence. middot Proficient in the use of a personal computer with experience in Microsoft Word, Excel, Power Point, Microsoft Project, network systems (electronic mail) and Internet applications. middot Minimum of 5 years direct work experience in a regulatory role and a demonstrated success in organizing and conducting FDA meetings and filing regulatory submissions Experience in U.S. Medical Device Regulations, including Quality Systems Regulations (QSRs), ISO 13485, Establishment registration, UDI labeling, and CE Marking requirements