Project Management (Clinical , IVDR)

Project Manager
6+ months contract to start with (extendable and potential to convert full time)
Location: Tarrytown, NY

The Project Manager is responsible for the planning, scheduling, tracking, coordinating, and monitoring of clinical technical files to ensure timely completion and approval of those files for compliance with IVDR regulations. S/He will work with and report to the IVDR Implementation Team Lead. 
 As a Project Manager, responsibilities include: 
 • Work with a cross-functional team to ensure the required documentation is properly completed in support of regulatory submissions for in vitro diagnostic products 
 • Track progress of each clinical portion of Technical File to confirm all deliverables are met and are in compliance with IVDR requirements 
 • Capture gaps, and manage activities to verify closure of clinical affairs tasks 
 • Resolve issues that arise within the clinical team 
 • Ensure that the project stays on schedule 
 • Support the IVDR Implementation Team Lead in managing completion of Technical Files, working closely with the IVDR Project Lead 
 • B.A./B.S. or equivalent; typically 10 plus years of industry experience, including 5 years of experience managing complex projects; successful demonstration of key responsibilities and knowledge as presented above 
 • Project Management Professional (PMP) certification not required but is a key differentiator 
 • Strong IVDR and / or MDR understanding and working knowledge 
 • Knowledge and experience with global registrations of in vitro diagnostic devices or medical devices a plus 
 • Strong technical background, preferably in the in vitro diagnostics or medical device industry 
 • Strong analytical skills to assess situations and drive decision making 
 • Strong interpersonal, communication and organizational skills required 
 • Must possess a high level of critical and strategic thinking skills and be a detail oriented team player 
 • Must be able to set priorities as well as adapt to changing priorities 
 • Ability to function in a changing, high-impact position, with deadline and resource constraints 
 • Demonstrated effective written and oral communications skills. Familiarity with key software and decision making tools 

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