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Senior Manager, Regulatory Affairs – Heart Valve Therapy

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

Job Description

The RA Sr. Manager 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 RA on a diverse array of regulatory initiative teams, manufacturing support, and new product development, with the goal of commercializing new technologies, as well as ensuring the sustained success of marketed products. The candidate we seek will demonstrate the ability to develop a variety of solutions to regulatory challenges and will exercise independent judgment in determining and communicating appropriate regulatory action and requirements. 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. 

You will collaborate with cross-functional teams, make presentations to management teams, and mentor Regulatory Affairs team members to share regulatory affairs knowledge.

Interact with the FDA and other approval authorities to negotiate evidence needs, and facilitate global approval of emerging technologies and changes to existing approvals. Prepare, provide direction and oversee document packages for submission to global regulatory agencies. These could include Pre-Submission 510(k), IDE, PMA, Annual Reports, CE submissions and change notices.



Job Requirements 

  • A Bachelor’s degree is required, preferably in a scientific discipline.
  • Requires a minimum of twelve years’ experience in Regulatory Affairs; minimum of 10 years’ experience in RA with a Master’s degree.
  • Proven experience in interactions with regulatory bodies.
  • Experience in preparing FDA and EU product submissions 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.
  • Requires a strong working knowledge of US and EU regulations that affect Class I, II and III devices; strong knowledge of global regulations a plus.
  • Demonstrated understanding of regulatory requirements for promotional materials; experience in review and approval of promotional materials is a plus.
  • Requires familiarity with new product development systems.
  • Requires the ability to travel 10% of the time.
  • Excellent writing and verbal communication skills across all levels
  • Strong strategic thinking, problem-solving and analytical ability.
  • Ability to multitask and balance competing priorities. 

 

Please apply online at: https://edwards.taleo.net/careersection/jobdetail.ftl?job=012768&lang=en