Position: Regulatory Engineer

Location : Fridley, MN Onsite only

Type: Contract



Industry: Regulatory, Medical devices, Companies: Medtronic, Stryker,
Zimmer, Johnson & Johnson, GE(Medical Device), Phillips (Medical Device),


- 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.



Reference : Regulatory Engineer jobs