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Manager, Regulatory Affairs - Critical Care

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

Join the global leader in hemodynamic monitoring. The Regulatory Affairs Manager role represents an excellent opportunity to join a high growth, innovative and industry leading organization. The candidate will represent Regulatory Affairs on a diverse array of new product development and manufacturing support teams with the goal of commercializing new and innovative Critical Care technologies, as well as ensuring the sustained success of marketed products.  The Manager will work on multiple projects where analysis of situations or data requires an evaluation of intangible variables for established products as well as new/emerging technology with no or limited history.  This role will involve assessment of regulatory impact for new and modified Class I, II and III products, including identification of assumptions/risks/mitigations to develop and execute clear regulatory plans. Requires strategic planning, preparation and management of regulatory submissions for US, EU and/or International submissions (e.g. 510(k)s and Letters to File, De Novo applications, FDA Pre-Submissions, CE Technical Files and Design Dossiers, and Change Notifications). 

 

  • Requires a minimum of 10 years’ experience in Regulatory Affairs.
  • A Bachelor’s degree is required, preferably in a scientific discipline. Requires the ability to travel 10% of the time (domestic and/or Europe).

 

Job Requirements (up to 200 words): 

  • Requires a minimum of 10 years’ experience in Regulatory Affairs. Medical device experience in other areas may be considered.
  • A Bachelor’s degree is required, preferably in a scientific discipline. An advanced degree in the sciences, Ph.D., or a combination of an MBA or J.D. with a science degree is preferred.
  • Experience in reviewing new and modified products for regulatory impact, determining appropriate global regulatory requirements, and preparing domestic FDA and EU product submissions is required.
  • Demonstrated understanding of basic regulatory requirements for promotional materials. Experience in review and approval of promotional materials is a plus.
  • Requires a strong working knowledge of US/EU regulations that affect Class I, II and III devices; and a good understanding of global regulations.
  • Excellent writing and verbal communication skills; and strong strategic thinking, problem-solving and analytical ability.
  • Ability to influence others at all levels of the organization is essential.
  • Results oriented, positive “can do” attitude.  Demonstrates a sense of urgency; understands the importance of outperforming and outpacing the competition in meeting customer’s and patient’s needs
  • A “hands-on” individual who enjoys challenge, is capable and dedicated to getting the job done with minimal direction.
  • Requires the ability to travel 10% of the time (domestic and/or Europe). 

 

Please apply online at:

https://edwards.taleo.net/careersection/jobdetail.ftl?job=011342&lang=en