Senior Specialist, Regulatory Affairs - Critical Care
July 30, 2018
Full Time - Experienced
4 Year Degree
Outstanding opportunity to be a part of a forward thinking regulatory affairs organization. The Senior Specialist, regulatory Affairs 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 Sr. 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.
Qualifications/Required Skills/Experience and Education:
A minimum of five years of experience within medical device regulatory affairs is required, for the Sr. RA role.
A Bachelor’s degree is required. A science degree is strongly preferred.
Experience with Class II devices preferred. Relevant experience includes, experience with hemodynamic monitoring devices.
Experience in preparing US and EU product submissions are required.
Must be competent in applying the appropriate l 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.
Internal Number: 014406
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.