Regulatory Affairs Specialist - Denver Colorado

Company: VirtualVocations
Location: Denver, Colorado
Posted On: 01/29/2025

A company is looking for a Regulatory Affairs Specialist I - Kitting.



Key Responsibilities

Assist in the development and implementation of regulatory strategies for new products and design control processes
Review labeling and Copy & Claims requests for compliance with internal procedures and FDA requirements
Coordinate regulatory submissions and maintain global regulatory compliance with relevant agencies



Required Qualifications

Bachelor's degree in biological sciences, microbiology, chemistry, or engineering; graduate studies in Regulatory Affairs preferred
3+ years of experience in Regulatory Affairs, preferably in a medical device company
Experience communicating with FDA and other regulatory agencies
Working knowledge of ISO and international regulations
Intermediate proficiency in Microsoft Office programs More...

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