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Senior Specialist, Regulatory Affairs - Critical Care

Company: Edwards Lifesciences
Location: Irvine
Posted on: October 15, 2020

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: 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. Qualifications/Required Skills/Experience and Education: A minimum of five years of experience within medical device regulatory affairs is required with a Bachelor's degree, OR a minimum of three years of experience is required with a Master's degree. A Bachelor---s degree is required. A science/engineering degree is strongly preferred. Must possess a strong working knowledge of US /EU regulations that affect Class II and/or Class III devices. Experience with US Class II devices and 510(k) submissions is required, Class III experience is a plus. Experience in preparing US and EU product submissions are 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 the regulatory impact of class II and III devices. --- Requires familiarity with new product development systems. Must have strong written and verbal communication skills, and have experience working on cross functional project teams. Strong ability to problem solve and apply analytical thinking is required. Experience with hemodynamic monitoring devices, software in a medical device, software as a medical device, mobile applications, algorithms, preferred. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Keywords: Edwards Lifesciences, Irvine , Senior Specialist, Regulatory Affairs - Critical Care, Other , Irvine, California

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