Regulatory Affairs Professional

1 day ago


StocktononTees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time
Job Overview
Fujifilm Corporation is a leading innovator in diagnostic and enterprise imaging solutions. As a Regulatory Affairs Professional, you will support full compliance to U.S. FDA medical device regulations, ISO 13485 standard requirements, and other applicable laws.

About the Role
This position requires three or more years of experience performing regulatory affairs support activities in a U.S. FDA regulated environment. You will be responsible for designating responsible personnel for device marketing authorization and facility registration, preparing European Union Technical Files, and evaluating customer complaints.

Required Skills
* Bachelor's degree highly preferred* Broad knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807)* Excellent leadership, communication, collaboration, team work and interpersonal skills

Estimated Salary Range
$70,000 - $90,000 per year based on location and experience.

About Fujifilm Corporation
Fujifilm is an equal opportunity employer committed to diversity and inclusion.

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