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Regulatory Engineer
Job in
Minneapolis, Anoka County, Minnesota, 55432, USA
Listed on 2026-08-05
Listing for:
Software Technology, Inc.
Full Time
position Listed on 2026-08-05
Job specializations:
-
Engineering
Biomedical Engineer, Medical Device Industry
Job Description & How to Apply Below
Regulatory Engineer
Location:
Fridley, MN - Remote
Regulatory knowledge (European Medical device directive and medical device Regulation)
Familiarity with standard related to Quality Management Systems (ISO 13485, 21
CFR Part 820)
Regulatory experience in Medical Device Registration Support- APAC, LATAM, EMEA, Canada, China, Russia, Japan. Medical device more relevant.
EUMDR- EUMDD STED writing experience, EUMDR remediation experience.
Project Management experience
Experience in Regulatory assessment of Engineering/ Design change execution
Very good written and oral communication in English.
Ease for reading/creating/modifying documents.
Able to work with minimal supervision. Self-motivated team player.
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