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Senior Specialist, Regulatory Affairs - Critical Care

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

Job Description: 

The RA Specialist role presents an exciting opportunity to join a forward thinking RA organization. The Specialist will focus on supporting sustaining engineering for our Critical Care monitoring products. This opportunity presents a unique challenge in refreshing our submissions. We are looking for a diligent RA professional who works well across functional teams, takes initiative, and enjoys working in a fast paced team environment. 

  • Represent regulatory affairs on sustaining engineering, product development and commercialization teams related to Critical Care Monitoring Products.
  • Interacts with FDA and 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.
  • Responsible for regulatory review for claims support of promotional material, labeling content, product and process changes, and product documentation.
  • Able to collaborate and take direction from team leaders, while working with RA management on resolution of RA issues and strategy.

Job Requirements:

  • A Bachelor’s degree is required.
  • A minimum of two years’ experience with class II/III medical devices is required.
  • Experience in preparing US and EU product submissions are strongly recommended.

Please apply online at: