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Regulatory Affairs Specialist II - Contract

Location: Hercules, CA, United States
Job # 10917478
Date Posted: 05-01-2018
Title: Regulatory Affairs Specialist II - Contract
Location: Hercules, CA 94547
Salary: Up to $55.00 hourly
6 Month Contract

Summary:
Our client, a leading producer of products for the life sciences and clinical diagnostics industry is seeking a Regulatory Affairs Specialist II to work within the RA and labeling groups. In this role, you will provide support and clarity on China IVD regulations, assisting with real time translations of Chinese documentation and labeling, as well as support effective communications with the China RA team. 

Job Responsibilities:
  • Perform product registrations with a concentration on the registration documentation required for China. 
  • Provide support for project teams for registration strategies with a focus on China. 
  • Provide Mandarin translations for RoHS element tables that are required by the Chinese Regulatory. 
  • Help support the communication meetings and daily communication with the China team. 
  • Help support and manage the labeling (LDR) process using EtQ.
  • This includes the support of ongoing labeling efforts (creating and revising labeling) for current Division projects
  • Help with the task of translations management, review and/or layout as needed.
Qualifications and Experience:
  • Demonstrated ability to communicate effectively in Mandarin. 
  • Demonstrated ability to work with individuals at all levels, both internal and external to the organization
  • Demonstrated ability to toggle between multiple priorities
  • Proven ability to work independently
  • Ability to prioritize tasks and exercise good judgment
  • Excellent attention to detail and the ability to produce work with a high level of accuracy.
  • Experience with foreign product registrations and EU technical file and registrations.
Please submit an updated version of your resume for immediate confidential consideration. Thank you.
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