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Senior Specialist, Regulatory Affairs - Critical Care

Company Name: Edwards Lifesciences LLC
Location: Irvine, CA
Job Type: Full-Time/SEE
Contact Name: Julia Kern
Phone:
Fax:
Email: apply directly online
Salary:

Job Description: 

This is an outstanding opportunity to be a part of a forward thinking regulatory affairs organization. The Senior Specialist, Regulatory Affairs will focus on supporting projects for our critical care products. We are looking for a diligent Sr. RA professional who works well across functional teams, takes initiative, and enjoys working in a fast-paced team environment. 

Job Description: 

  • Participate as an active member of the EU MDR transition team.
  • Represent regulatory affairs on product development, commercialization, and sustaining teams related to Critical Care Products.
  • Interacts with FDA and other regulatory bodies under management guidance 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
  • May provide 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 in a related field is required; a scientific discipline is preferred.
  • A minimum of five years of related experience is required with a Bachelor’s degree, OR, a minimum of three years of related experience is required with a Master’s degree. 
  • Experience with Class II devices is required. Experience with hemodynamic monitoring devices is preferred.
  • Experience preparing US and EU product submissions is required. Knowledge of EU MDR is preferred. Knowledge of Canada, Australia, and New Zealand submissions preferred.
  • Must be competent in applying the appropriate regulatory requirements for new products or product changes as it relates to labeling (and advertising) of class II and III devices. – Requires familiarity with new product development systems.
  • Must possess a strong working knowledge of US /EU regulations that affect Class II and/or Class III devices.
  • Must have strong written and verbal communication skills, and have experience working on cross functional project
  • Strong ability to problem solve and apply analytical thinking is required.

 

Please apply online at: https://edwards.taleo.net/careersection/jobdetail.ftl?job=017541&lang=en