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EUDAMED Project Manager

Company: Radiant System, Inc
Location: Sunnyvale
Posted on: June 21, 2019

Job Description:

The EUDAMED Project Manager Compliance Programs will be the business liaison for the MDR Program with Our client internal IT department. They will be responsible for identifying activities, monitoring progress, and ensuring timely project delivery for IT projects associated with the EU Medical Device Regulation including EUDAMED and supporting technologies including but not limited to Product Data Management and relational artifact management a required by MDR. Job Description Be the single point of contact between MDR program and supporting IT project(s) Lead coordination of cross functional business project team and IT in the creation of project deliverables and realistic timelines and defined resource requirements Work with compliance process architects, business analysts, data governance and IT team members to identify solution(s) and potential solution gaps Coordinate business requirements, solution design, testing and validation resources to achieve milestones required by projects Identify project risks, develop mitigation strategies, and monitor required issues and actions to support solution delivery. Utilize project management tools and templates (project plans and trackers) to drive consistency across project(s) workstreams Leverage well developed interpersonal skills to build and maintain positive working relationships with functional groups throughout the organization. Present concise information as needed to senior management regarding progress of project activities and commitments. SkillJob Requirements Bachelor s Degree or related equivalent work experience required Experience andor deep working knowledge of compliance requirements associated with EU Medical Device Regulation, FDA Unique Device Identification (UDI) and related standards (i.e. GS1 Global Trade Identification Numbers) A minimum of 5 years of experience in IT program or project management preferably within a regulated industry such as medical devices, healthcare, or pharmaceuticals required Experience with complete System Development Lifecycle programs including General Principles of Software Validation as defined by the FDA required System knowledge of Product Lifecycle Management (e.g. Agile) ERP, Master Data Management and .xmlAS2 communication exchange protocols required Strong communication and presentation skills required Experience with compliance Regulations etc strongly preferred Experience with MS Project, Microsoft Excel, Word, PowerPoint andor other standardized project management toolsdocumentation preferred

Keywords: Radiant System, Inc, Oakland , EUDAMED Project Manager, Executive , Sunnyvale, California

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