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Project Manager - MDR EUDAMED

Company: Maxonic, Inc.
Location: Sunnyvale
Posted on: June 27, 2019

Job Description:

Project Manager - MDR EUDAMED Our direct client is one of the American multinational Medical Appliances Equipment Industry. This Contract role located in Sunnyvale, CA DUTIES RESPONSIBILITIES Primary function of position The EUDAMED Project Manager Compliance Programs will be the business liaison for the MDR Program with ISI 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 About Maxonic Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 5,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients. Interested in Applying? Feel free to email Suresh M () or call 408-715-1210 ext 113.

Keywords: Maxonic, Inc., Santa Rosa , Project Manager - MDR EUDAMED, Executive , Sunnyvale, California

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