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Manager, Regulatory Affairs - Transcatheter Mitral and Tricuspid Therapies

Company Name: Edwards Lifesciences LLC
Location: Irvine, CA
Job Type: Full-time, Salary exempt
Contact Name: Patricia Forrest
Phone:
Fax:
Email: apply directly online
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 Regulatory Affairs function on a variety of Product Development Teams with a goal of commercializing a new and innovative technology. 

  • 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).
  • Prepare IDE and PMA annual reports as well as Justifications to File.
  • Assume regulatory review of promotional material, labeling content, product and process changes and product documentation.
  • Act as liaison with government officials in support of product approvals.
  • Demonstrate the ability to develop a variety of solutions to regulatory challenges.
  • Exercise independent judgment in determining appropriate regulatory action and requirements for new product or product changes and preparation of regulatory documents.
  • Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
  • Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  • Ensure schedules and performance requirements are met.
  • Manage and mentor junior members of the RA team. 


Job Requirements 

  • Requires a minimum of ten years experience in Regulatory Affairs. Medical device experience in other areas may be considered.
  • Experience in developing new product registration/dossiers for domestic FDA and EU product submissions is required.
  • A Bachelor’s degree is required, preferably in a scientific discipline.
  • 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.
  • Experience in review and approval of promotional materials is a plus.
  • Experience in the cardiovascular device space is highly desirable.
  • Requires familiarity with new product development systems; a strong working knowledge of all U.S. regulations that affect Class II and Class III devices; a strong understanding of global regulations; excellent writing and verbal communication skills; and strong problem-solving and analytical ability.

 Please apply online at: https://edwards.taleo.net/careersection/jobdetail.ftl?job=012564&lang=en