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Senior International Regulatory Affairs Manager - 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

Our innovative Critical Care business unit seeks a Senior International Regulatory Affairs Manager to oversee Regulatory submissions to all countries outside of the United States and the European Union (including Great Britain).  This individual will provide country specific RA input to new product development and manufacturing support teams and ensure that all NPD documentation is provided to the countries on site RA teams per the project plan schedule. The Sr. Manager will track all required recertification’s to ensure that there is no lapse in approvals globally and audit the EU tech files annually to ensure that they are citing the current standards. 

Additional Responsibilities will include:

  • Manage a team of 3+ professionals
  • Interact with the RA teams in country
  • As required act as liaison with government
  • May work on new/emerging technology that has no or limited history
  • Demonstrate the ability to develop a variety of solutions to regulatory challenges
  • Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
  • Ensure schedules and performance requirements are met. Erroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.


Job Requirements (up to 200 words): 

Qualifications:

  • Requires a minimum of ten years’ experience in Regulatory Affairs. Medical device experience in other areas, may be considered.
  • Experience in supporting and maintaining international product approvals 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 competence in project management skills.
  • Experience in review and approval of promotional materials is a plus.
  • Requires familiarity with new product development systems; a working knowledge of all U.S. regulations that affect Class II and Class III devices; a strong working knowledge of global regulations; excellent writing and verbal communication skills; and strong problem-solving and analytical ability.
  • Ability to work collaboratively in a fast moving highly matrixed organization.

  

Please apply online at:

https://edwards.taleo.net/careersection/jobdetail.ftl?job=011347&lang=en