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Specialist, Regulatory Affairs - Transcatheter Mitral & Tricuspid Therapies

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

Job Description (up to 200 words): 

The RA Specialist will focus on supporting US/EU submissions. This opportunity presents a unique opportunity to lead the way in the Transcatheter Mitral and Tricuspid Therapies and cutting edge technology. 

  • Prepare documentation packages for submission to regulatory agencies. May interact with regulatory agencies as part of submission review and on-site audit support.
  • Represent regulatory affairs on product development and commercialization teams related to TMTT
  • Provide technical review of protocols/reports/technical documents that will be incorporated into regulatory submissions to ensure scientific rigor, accuracy and clarity of presentation.
  • Monitor proposed and current US and EU regulations and guidance, and advise the impact of such regulations and guidance on assigned projects.
  • Coordinate submission activities for recall/field notifications as needed.
  • Responsible for regulatory review for claims support of promotional material, labeling content, product and process changes, and product documentation.
  • Collaborate and take direction from team leaders, while working with RA management as required.
  • Additional Regulatory Affairs related projects as assigned. 

Job Requirements (up to 200 words): 

  • A minimum of three years of experience within medical device regulatory affairs
  • A Bachelor’s degree is required.
  • Must have strong written and verbal communication skills, and have experience working on cross functional project 

Please apply online at: https://edwards.taleo.net/careersection/jobdetail.ftl?job=014036&lang=en