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Senior Manager, Regulatory Affairs - Transcatheter Heart Valve

Company Name: Edwards Lifesciences LLC
Location: Irvine, CA
Job Type: Full-Time / SEE
Contact Name: Julia Kern
Phone:   
Fax:  
Email: apply directly online
Salary:

Job Description:

The Senior Manager, Regulatory Affairs Program Management role represents an excellent opportunity to join a high growth, innovative and industry leading organization and advance a career in the Regulatory Affairs function. The successful candidate will represent the Regulatory Affairs function on a variety of Manufacturing and New Product Development Teams related to our exciting and leading-edge Transcatheter Heart Valve business. These projects generally have durations ranging from months to years.

Key Responsibilities:

  • US and European regulatory affairs with some interface with global partners
  • Determining regulatory paths for new product development, product and process change control
  • Writing and/or submitting technical documents including 510(k)s, IDEs, PMAs, CE Technical Files/Dossiers and clinical trial protocols/updates
  • Provide regulatory review/approval of labeling and act as liaison with FDA and the Notified Body in support of product approvals
  • Support project teams with global regulatory strategies
  • Provide review and input of protocols and reports for: design verification, design validation, process qualifications, biocompatibility studies, shelf life, pre-clinical studies, animal studies, and clinical studies
  • Monitor, research, and obtain information on FDA activities and proactively share information within Edwards - Effectively communicate with regulatory agencies 

Job Requirements: 

  • A Bachelor’s degree is required; a scientific discipline is preferred
  • Requires a minimum of twelve (12) years of related experience with a Bachelor’s degree, or ten (10) years of related experience with a Master’s degree 

Required Skills: 

  • Excellent written and verbal communication skills
  • Experience working on cross-functional project teams
  • Expert knowledge of all U.S. regulations that affect Class II and III devices
  • Expert knowledge of European regulatory requirements for Class IIa/b/III devices
  • Basic understanding of other global regulations
  • Strong problem-solving and analytical ability 

Please apply online at: https://edwards.taleo.net/careersection/jobdetail.ftl?job=016750&lang=en