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Senior Manager, Regulatory Affairs Program Management - Heart Valve Therapy

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 Sr. Manager. Program Mgmt. will represent the Regulatory Affairs function on a variety of Manufacturing and New Product Development Teams related to the HVT business. Serve as a subject matter expert on a diverse array of topics from regulatory strategy, change management, compliance, and emerging global regulations across the department for various projects and Business Unit or Corporate initiatives. 

  • Provide subject matter expertise to HVT regulatory personnel on regulatory requirements primarily for US and Europe, but also international.
  • Drive continuous improvement & innovation within the HVT RA function as relates to procedures and processes.
  • Serve as compliance manager and support regulatory affairs aspects of CAPAs, field actions, and Patient Risk Assessment for HVT product portfolio, as well as managing and supporting internal and external audits.
  • Write and/or submit 510(k)s, IDEs, PMAs, Technical Documentation, Post Market Reports, etc.
  • Monitor and participate in industry associations such as AdvaMed and proactively share information with management in HVT and Edwards.
     

Job Requirements: 

  • Bachelor’s degree required
  • Minimum 12 years RA experience in medical device industry
  • Expert knowledge of all U.S. regulations that affect Class II/III devices
  • Expert knowledge of European regulatory requirements for Class IIa/b/III devices

 
Please apply online at: https://edwards.taleo.net/careersection/jobdetail.ftl?job=014374&lang=en

 

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