Regulatory Affairs Specialist

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POST DATE 9/15/2016
END DATE 10/30/2016

Modis Irvine, CA

Company
Modis
Job Classification
Full Time
Company Ref #
23180929.21601004
AJE Ref #
576184256
Location
Irvine, CA
Job Type
Regular
Required Licenses/Certifications
df-aj

JOB DESCRIPTION

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span B We are a global leader in advanced surgical technologies, specifically in spinal surgery. /B br B   /B br B Summary: /B br Responsible for regulatory functions to support our Irvine manufacturing site including support of FDA UDI requirements, serving as a regulatory representative on selected project teams for new product design as well s project teams for process development, develop departmental SOPs/policies regarding regulatory requirements and processes. br   br B Responsibilities: /B br ul
li Provide regulatory guidance to quality systems, manufacturing, marketing, product development groups. /li li Provide guidance and interpretation for regulatory issues for product development teams, assuring that design and development requirements are met. /li li Prepare and submit FDA filings for new products. /li li Maintain current status of FDA submissions,CE ark technical files and design project deliverable /li li Ensure regulatory compliance of manufacturing and operational processes: Review and approve MDRs, NCRs and deviations. /li /ul
  br B Requirements: /B br ul
li BS in scientific field /li li Background in Medical Devices or products dealing with blood, human, cell and tissue /li li Proven ability to prepare  and submit documents to FDA such as: 510k premarket notifications, Investigational Device Exemptions, and premarket approval applications /li li Experience with blood, human, cell and tissue based products experience is highly desired. /li /ul
  br If you are interested in this position please apply or send your resume (Email Address Withheld by Request). br /span