- Project Management, Medical Device, Regulatory assessment
- Contract W2, Contract Independent, Contract Corp-To-Corp, 2 Years
- Depends on Experience
Experience: 1-6 yrs.
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.