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.