Specialist 3 - Regulatory Affairs

Responsibilities

• Prepare regulatory documentation to support the market distribution of new and modified medical devices (510(k)/NTF) in US, Canada, and EU.
• Support global registrations in rest of world.
• Review device Labeling, including all graphic material.
• Prepare export certificates, medical device listings, annual establishment registrations for submission to the U.S. Food and Drug Administration (FDA).
• Auxiliary work includes assisting the Regulatory Manager with special projects as needed.

Requirements

• BS Degree in Science or Engineering required.
• Four to six years related regulatory experience in medical devices or relevant medical device industry experience.