Job Description :

Role: Regulatory Engineer
Location: Fridley, MN

Duration: 6-12+ Months contract
Experience: 1-6 yrs.
•         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.


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