Vacancy caducado!
Role: Regulatory Engineer (3 positions) Location: Fridley, MN 55446, USA 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.
Vacancy caducado!