Sign up  

Follow Us!

Senior Manager, Regulatory Affairs - Transcatheter Mitral and Tricuspid Therapies

Company Name: Edwards Lifesciences LLC
Location: Irvine, CA
Job Type: Regulatory Affairs
Contact Name: Patricia Forrest
Phone:
Fax:
Email: apply directly online
Salary:

Job Description

The Sr. Manager, Regulatory Affairs role represents an excellent opportunity to join a high growth, early-stage product development group, Transcatheter Mitral and Tricuspid Therapies (TMTT) focused on developing solutions for patients suffering from structural heart disease. Represent regulatory affairs on product development and commercialization teams related to TMTT.

  • Interacts with FDA and/or other regulatory bodies for submissions and projects.
  • Will monitor proposed and current US and EU regulations and guidance, and will advise the impact of such regulations and guidance on the company within the scope of assigned.
  • Able to collaborate and take direction from team leaders, while working with RA management on RA strategy for US IDE, US PMA, CE Trial, CE Mark, as required.
  • Prepares document packages for submission to global regulatory agencies (IDEs, PMAs, AR, 510(k)s and CE marking design dossiers and technical files). Prepare IDE and PMA annual reports and 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.
  • Work on multiple projects where analysis of situations or data requires an evaluation of intangible variables.
  • May work on new/emerging technology that has no or limited history.

Job Requirements (up to 200 words): 

Qualifications:

  • Requires a minimum of twelve years’ experience in Regulatory Affairs. Medical device experience in other areas, may be considered.
  • Experience in preparing domestic FDA and EU product submissions 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.
  • Demonstrated understanding of basic regulatory requirements for promotional materials.
  • Experience in review and approval of promotional materials is a plus.
  • 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.
  • Ability to travel 25 % 

 

Please apply online at:  https://edwards.taleo.net/careersection/jobdetail.ftl?job=010631&lang=en