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Senior Specialist, Regulatory Affairs (Sustaining) - Transcatheter Heart Valve

Company Name: Edwards Lifesciences LLC
Location: Irvine, CA
Job Type: Full-Time/SEE
Contact Name: Julia Kern
Phone:
Fax:
Email: apply directly online (see below)
Salary:

Job Description

Edwards Lifesciences is looking for a Senior Regulatory Affairs Specialist to play a key role as part of a high-performing Regulatory Affairs team in the Transcatheter Heart Valve business. This role is responsible for supporting multiple products in the percutaneous treatment of cardiac valve disease. 

  • Represent the regulatory function on sustaining manufacturing and product development teams
  • Prepare documentation packages for submission to global regulatory agencies. Track timelines and documents milestone achievements for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support (e.g., IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE marking design dossiers and technical files).
  • Monitor proposed and current global regulations and guidance;
  • Review labeling content, product and process changes, and product documentation
  • Prepare documents for submissions, assuring the appropriate forms for all of the global regulatory bodies; assist with GUDID submissions. 

Job Requirements:  

  • A minimum of five years of regulatory affairs experience within medical device is required with a bachelor’s degree, OR, a minimum of three years of regulatory affairs experience within medical device is required with a Master’s degree. 

  

Please apply online at: https://edwards.taleo.net/careersection/jobdetail.ftl?job=015748&lang=en

 

 

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