Edwards Lifesciences Specialist, Regulatory Affairs - Transcatheter Mitral & Tricuspid Therapies in Irvine, California
The Regulatory Affairs Specialist will focus on supporting US and EU submissions. This opportunity presents a unique opportunity to lead the way in the Transcatheter Mitral and Tricuspid Therapies and cutting edge technology.
Prepare documentation packages for submission to regulatory agencies. May interact with regulatory agencies as part of submission review and on-site audit support.
Represent regulatory affairs on product development and commercialization teams related to transcatheter mitral and tricuspid therapies.
Provide technical review of protocols/reports/technical documents that will be incorporated into regulatory submissions to ensure scientific rigor, accuracy and clarity of presentation.
Monitor proposed and current US and EU regulations and guidance, and advise the impact of such regulations and guidance on assigned projects.
Coordinate submission activities for recall/field notifications as needed.
Responsible for regulatory review for claims support of promotional material, labeling content, product and process changes, and product documentation.
Collaborate and take direction from team leaders, while working with RA management as required.
Additional Regulatory Affairs related projects as assigned.
A minimum of three years of experience within medical device regulatory affairs
A Bachelor’s degree is required. A science degree is strongly preferred.
Must possess a strong working knowledge of US /EU regulations that affect Class III devices.
Must have strong English written and verbal communication skills, and have experience working on cross functional project
Strong ability to problem solve and apply analytical thinking is required.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes 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.
Title: Specialist, Regulatory Affairs - Transcatheter Mitral & Tricuspid Therapies Location: USA-USA-California - Irvine Job Number: 014018