Role - EU MDR Labeling Workstream - Label Approval Process Efficiency Implementation
High-Level Responsibilities: - Draft, socialize and finalize Project Charter - Create and maintain overall project plan - Management of issues/risks - Lead the development of a capability/small team to own and manage the administrative tasks required for the device label and instructions for use (IFUs) change approval process - Manage day-to-day project needs within the dedicated team with direction and support from the *** Business Lead - Analyze results from established reporting and make adjustments to the team/process as necessary - Create monthly status reporting documents
Sillset/Experience: - Solid analytical capabilities ? able to review reporting data and determine appropriate actions based on data trends, patterns, etc. - Competency in process/value stream mapping - Strong problem-solving capability - Lean Six Sigma Training ? Green Belt certification is preferred - Preferred ? prior project experience within the Medical Device industry - Preferred ? prior experience with Regulatory project work - 3-5 years minimum project management experience
Responsibilities may include the following and other duties may be assigned. Leads and directs one or more project teams engaged in global initiatives across functional and regional organizations. Develops and manages all facets of the project(s) from intake through implementation and closure. Accountable for the successful implementation of the outcomes derived through the change through effective organization and leadership, business case and benefits management, stakeholder management, risk management and issue resolution, planning and control, change management and quality management. Ensures the project adheres to all Corporate and IT policies and standards. Responsible for effectively managing the constraints of project management: Scope, Cost, Schedule. Provides technical and analytical guidance and recommendations to leadership governance bodies. Keeps current on advances and best practices in project management methodologies.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience. Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task