Excyl, Inc.

Regulatory Engineer

Excyl, Inc. Minneapolis, MN
Excyl, Inc.

Regulatory Engineer

Excyl, Inc. Minneapolis, MN
3 months ago
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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.

Ali

Excyl, Inc.

Email: mubasher.ali@excyl.com

  • Seniority level

    Entry level

  • Employment type

    Full-time

  • Job function

    Other

  • Industries

    IT Services and IT Consulting

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