Project Manager II
Andover, MA Posted: 11/4/2019
Our client is an International Medical Device organization that has over 70,000 employees worldwide. With over 100 years in the Healthcare Industry, our client has multiple product lines ranging from Class 1 to Class 3 medical devices. Our client specializes in data analytics, diagnostic technologies, clinical monitoring, and Imaging Systems.
Experience: Five (5) or more years professional experience, three (3) or more of which are experience in the Medical Device space required. Bachelor's Degree or equivalent. Engineering degree preferred, experience in quality and regulatory preferred.
Tasks: Coordinate Supplier facing activities for compliance of already marketed products to the new EU MDR 2017/745. Tasks:1) Facilitate internal alignment on execution plans to regulatory strategies in place. 2) Facilitate Supplier communication and negotiation. 3) manage supplier technical data to the satisfaction of internal regulatory advisors. 4) Support suppliers in creating and maintaining a regulatory filing project plan that captures tasks, milestone dates, status and resource plans.Experience in managing and writing contracts is a plus.
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