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Sr. Manager, International Regulatory Affairs - Transcatheter Mitral and Tricuspid Therapies

Company Name: Edwards Lifesciences LLC
Location: Irvine, CA
Job Type: Regulatory Affairs
Contact Name: Patricia Forrest
Phone:
Fax:
Email: apply directly online
Salary:

Job Description

          Sr. Mgr., Int’l Regulatory Affairs will ensure compliance of Edwards’ products with regulatory requirements TMTT. 

  • Define and execute Regulatory strategies for international pre-approval clinical studies, post-approval clinical studies and international commercialization in collaboration with in-country counterparts.
  • Provide Regulatory strategic direction and coordination for TMTT international product launches.
  • Provide subject matter expertise and/or leadership to TMTT RA organization on international Regulatory requirements including European, Japan / Asia Pacific, and Latin America.
  • Deliver project/change management expertise, strategic planning, and implementation support for key TMTT RA organizational initiatives.
  • Drive continuous improvement & innovation within the TMTT RA function.
  • Enhance and strengthen the communication processes between International RA and the Business Unit Regulatory Affairs team.

Job Requirements (up to 200 words):  

  • The ideal candidate will be able to evaluate global directives, assess the ramifications to Edwards’ business and develop regulatory solutions. He/she will work closely with the regulatory teams across the regions for all products within the TMTT portfolio.
  • Advanced Degree or country equivalent in science-related field.
  • Minimum 10+ years in medical device or pharmaceutical experience
  • Expert knowledge of regulations, current industry practices, and strong experience with interpretation and application of regulatory guidelines pertinent to a diverse drug/device portfolio.

Please apply online at: https://edwards.taleo.net/careersection/jobdetail.ftl?job=013854&lang=en

 

 

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