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Associate Manager, Regulatory Affairs - Transcatheter Mitral Valve Replacement

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

Job Description

The Associate RA Manager will focus on supporting US and CE Mark strategies and submissions. This opportunity presents a unique opportunity to lead the way in the transcatheter mitral valve space and cutting edge technology. 

  • Represent regulatory affairs on product development and commercialization teams related to TMTT replacement programs.
  • Interacts with FDA and other regulatory bodies.
  • Will monitor proposed and current US and EU regulations and guidance.
  • Responsible for regulatory review for claims support of promotional material, labeling content, product and process changes, and product documentation.
  • Able to collaborate and take direction from team leaders, while working with RA management on RA strategy for US IDE, US PMA, CE Trial, and CE Mark, as required.


Job Requirements 

  • Minimum 8 years of experience within medical device RA is required.
  • Bachelor’s degree is required.
  • Class III experience is required.
  • Experience in preparing US original IDE and PMA submissions and CE Mark Design Dossier submissions required.
  • Must be competent in applying the appropriate regulatory requirements for NP or product changes as it relates to Class III devices. Requires familiarity with new product development systems.
  • Must possess a strong working knowledge of US /EU regulations that affect Class III devices.z
  • Proven expertise in Microsoft Office Suite.  

Please apply online at: https://edwards.taleo.net/careersection/jobdetail.ftl?job=013566&lang=en