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jobs description

We are currently seeking a Senior Project Manager to join our Joint Replacement division to be located in Mahwah, NJ. Who we want Strategic. Creates alternative ways to proceed. Faced with any given scenario, can quickly spot the relevant patterns and issues. Focus. Takes direction, follows through, and makes the corrections necessary to stay on track. Prioritizes then acts. Collaborators. Collaborates and builds relationships with internal and external stakeholders. Teammates. Supports, encourages, and inspires others. Communicators. Articulates well and expresses ideas effectively. What you will do As a Senior Project Manager you will collaborate with all functions of the business in a highly visible role. You will manage the implementation and/or remediation of our products to External Standards to ensure our QMS is compliant with all applicable regulatory requirements and that our product portfolio is State of the Art (SOTA). This role will influence and drive meaningful change... helping the organization solve complex issues, working across all product portfolios, and working with various leadership to determine project priorities. Ensure various functions across the business maintain QMS and Product compliance including but not limited to procedural updates and product testing. Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables You will be responsible for partnering with cross functional teams to develop robust and risk-based solutions to complex standards requirements You will lead all External Standard remediation activities so that our product portfolio meets all current requirements Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance Responsible to improve team performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders May coordinate the activities of one or more exempt and/or non-exempt employees What You NeedBachelor's Degree (B.S. or B.A.) required. 7
years of related business experience required. 2
years of demonstrated experience managing projects in at least one discipline (RA, QA, R&D, Operations, etc.) required. Previous experience working in a FDA regulated industry required. A general understanding in regulatory affairs required. Knowledge of EU regulatory requirements including the MDD and MDR for medical devices required.
Salary Range:
$80K -- $100K
Minimum Qualification
Business Project ManagementEstimated Salary: $20 to $28 per hour based on qualifications
Mahwah NJ United States


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