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OCRA-DG - Manager, Regulatory Affairs - Transcatheter Mitral and Tricuspid Therapies
 
     
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Manager, Regulatory Affairs - Transcatheter Mitral and Tricuspid Therapies

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

Job Description

The Manager, Regulatory Affairs 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 RA functions on a variety of Product Development Teams with a goal of commercializing a new and innovative technology. 

The candidate we seek will demonstrate the ability to develop a variety of solutions to regulatory challenges and will exercise independent judgment in determining appropriate regulatory action and requirements for product changes and preparation of regulatory documents. He/she may interact directly with Regulatory Agencies under management guidance. 

  • Prepares document packages for submission to global regulatory agencies (ie, IDEs, PMAs, annual reports, 510(k)s and CE marking design dossiers and technical files).
  • Act as liaison with government officials in support of product approvals.
  • Demonstrate the ability to develop a variety of solutions to regulatory challenges.
  • Ensure schedules and performance requirements are met.
  • Manage/mentor a team of 2RA Specialist.


Job Requirements  

  • Requires a minimum of ten years’ experience in RA
  • A Bachelor’s degree is required
  • Demonstrated competence in working as part of a focused project team.
  • Demonstrated competence in determination of appropriate global regulatory requirements for new products or product changes.

Please apply online at: https://edwards.taleo.net/careersection/jobdetail.ftl?job=014836&lang=en

 

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