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Allendale, New Jersey - USD Full Time Posted: Friday, 14 September 2018
 
 
Job Description

Senior Regulatory Affairs Associate

Responsibilities

  • Support the implementation of eIFU by participating in the following activities:
  • Create plan for making single language IFUs from existing Multilanguage IFUs and uploading those files into an eIFU website.
  • Create a checklist in order to confirm all required verbiage and label elements are on single language file.
  • Obtain electronic files from current Translation Service Provider and extract single language text from software files.
  • Create new, single language file with all local language plus all necessary header and footer information.
  • Load approved files onto website
  • Maintain well-organized records that allow ready retrieval of required information
  • Participate on activities with external partners for eIFU related documentation requirements
  • Maintain adherence to the eIFU project schedule
  • Candidate is expected to work independently and be able to troubleshoot independently.

Qualifications

  • BA/BS Degree or equivalent experience
  • 3+ years of experience in medical or scientific field in Quality, Regulatory or equivalent
  • Experience with regulatory affairs labeling activitiesStrong communication skills are necessary. Project Management skills are a plus.
Company Description World's leading medical technology companies and offer a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine, which help improve patient and hospital outcomes.

Allendale, New Jersey, United States of America
IT
USD
Global Medical Device Manufacturing Company
Global Medical Device Manufacturing Company
JS72E3EA4A3/516463368
9/14/2018 3:38:50 PM

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