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Senior Specialist, Regulatory Affairs Int'l - Transcatheter Heart Valve

Company Name: Edwards Lifesciences LLC
Location: Irvine
Job Type: Full Time - regulatory affairs
Contact Name: Patricia Forrest
Email: Apply online at:  https://edwards.taleo.net/careersection/jobdetail.ftl?job=009441&lang=en
 

Job Description

In this position you will play a key role as part of a high-performing Regulatory Affairs team responsible for the supporting multiple products in the percutaneous treatment of cardiac valve disease. This business unit is expected to continue growing rapidly and this role could be a significant stepping stone in your career.

For more information about the Transcatheter Heart Valve (THV) visit: http://www.edwards.com/products/transcathetervalve/Pages/THVcategory.aspx

  • Work on Regulatory subteam responsible for support of international registrations.
  • Represent subteam directly and on project teams, etc., to the larger Regulatory group and other departments, both domestic and international. Support subteam members through cooperation and teamwork.
  • Develop strategies for obtaining regulatory approval of new products and changes to existing products and processes.
  • Work with overseas Regulatory affiliates to negotiate and define requirements for regulatory submissions, including new product dossiers, partial change amendments, annual reports, notifications, etc.
  • Prepare documentation meeting regulatory requirements, identifying and using existing documentation where possible, or managing creation of new documentation; provide to foreign Regulatory affiliates to support product registration.
  • Monitor regulatory environment in target countries, including proposed and current regulations and guidance documents; ensure regulatory strategies take it into account.

 

Job Requirements

Qualifications:

We are looking for individuals with 3-5 years of experience in Medical Device RA, preferably in Class III devices and with exposure to PMA products.

  • A minimum of three years’ experience within medical device regulatory affairs is required.
  • Experience with Class III devices preferred. Relevant experience includes interventional cardiology, stents, implantable devices, catheter delivery systems, orthopedics, cardiac surgery, heart valves or other innovative PMA devices.
  • Experience in preparing international product submissions.
  • A Bachelor’s degree is required.
  • Must be competent in interpreting global regulatory requirements for new products or product changes as it relates to Class II and III devices. Requires familiarity with new product development and product change control systems.
  • Must possess general working knowledge of global regulations that affect Class II and/or Class III devices.
  • Must have strong written and verbal communication skills, and have experience working on cross functional project teams.
  • Strong ability to problem solve and apply analytical thinking is required.
  • Must have proficiency in software applications (e.g., MS Word, Outlook, etc.).

 

Please apply online at:
https://edwards.taleo.net/careersection/jobdetail.ftl?job=009441&lang=en