NetSource, Inc.
Remote * (Winooski, VT, USA)
Please note that this is a 1 year contract position. This position can be remote and the candidates need to be on East Coast to be able to travel on-site if required. Description: We are looking for someone with strong knowledge and experience with the new IVDR regulations. Here are some other considerations: Proficient in Project Management Skills for R&D Product Development Excellent Communication Skills (Written and Verbal) Advanced Understanding of Product Safety Risk Management and Post Market Surveillance Advanced Understanding of the EU IVDR Regulations and other country regulations Understanding of Performance Evaluation Plans and Reports Understanding of Product Requirements, Specifications and Intended Use Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations. Prepares document packages for regulatory submissions for new...