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, 21CFR 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.