readiness team in a timely and professional manner. Requirements: Bachelor's degree in a scientific discipline such as life... sciences, pharmacy, bioscience; advanced degree preferred. 5+ years of experience in regulatory affairs within the...
Strong understanding of medical device product life cycle and regulatory requirements In-depth knowledge of ISO 13485, FDA regulations...
clinical development life cycle Compile, coordinate and review applications to Regulatory Authorities including...
Responsibilities: This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA and EU regulation...