• Project Management, Medical Device, Regulatory assessment
  • Contract W2, Contract Independent, Contract Corp-To-Corp, 2 Years
  • Depends on Experience

Job Description

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.

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