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Regulatory Compliance Manager
Medical Device/Quality/Compliance
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Location: Irvine, CA
Pay Rate: Contract: 52.88 to 56.73 $/hr
Salary: 110.00 to 118.00 K$/yr
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Position Type/ Job Duration: Direct hire
Education Required: BS 
Years Experience Required: 5

Industry:
Mfg
Job Posted: 12/13/2017
Should I worry about this date?
Apply Deadline: 12/18/2017
Job #: 134272R2K
Job order status: Client is actively seeking candidates
Relocation available: Not Available


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Our client in Irvine CA, is looking immediately to hire a full time Sr. RA Specialist who will be responsible to assist with the compliance of the Quality Systems, as well as facilitating continuous quality improvements and ensuring regulatory compliance. Relocation available

Responsibilities

  • Prepare and submit product registrations and submissions 510K's and PMA to FDA and other regulatory bodies.
  • Maintain company registrations and device listings in the US, Canada and the EU
  • Supports and maintains technical files, MDD certifications and declarations of conformity in support of EU product registrations - CE Mark
  • Recall Coordinator for product recalls
  • Reviews and writes standard operating procedures and other RA/QA policies
  • Works with technical staff to foster understanding of SOP's and guidance documentation

Requirements

  • 5 years of experience in RA related activities including SOP development, good practices training programs, and with GMP audits and inspections
  • BA or BS Degree from a four year college
  • Knowledge of RA/QA regulations and guidance such as GMP
  • Strong Experience with FDA 510K and ISO 13485

Benefits

  • Great company benefits, Health, Dental, 401K, and so much more!
  • Relocation
 
 
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