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Sr 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 on line (see below).
Salary:

Job Description

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

  • Represent regulatory affairs on product development and commercialization teams related to TMTT.
  • Prepare and oversee 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)
  • Will monitor proposed and current US and EU regulations and guidance, and will advise the impact of such regulations and guidance on the company within the scope of assigned
  • Responsible for regulatory review for claims support of promotional material, labeling content, product and process changes, and product documentation.
  • Additional Regulatory Affairs related projects as assigned.


Job Requirements 

  • Minimum of 5 years of experience within medical device RA
  • A Bachelor’s degree is required.
  • Must possess a strong working knowledge of US /EU regulations
  • Must have strong English written and verbal communication skills; experience working on cross functional projects
  • Strong ability to problem solve and apply analytical thinking

  

Please apply online at: https://edwards.taleo.net/careersection/jobdetail.ftl?job=014032&lang=en