Edwards Lifesciences Senior Specialist, Regulatory Affairs - Transcatheter Mitral and Tricuspid Therapies in Irvine, California
The Senior 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. Responsibilities:
Represent regulatory affairs on product development and commercialization teams related to TMTT.
Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans to teams for solutions.
Prepare and oversee documentation packages for submission to global regulatory agencies. Track timelines and documents milestone achievements for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support. (e.g., IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE marking design dossiers and technical files).
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 as required.
Additional Regulatory Affairs related projects as assigned.
A Bachelor’s degree is required. A science degree is strongly 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
Class II and Class III regulatory affairs experience within the medical device industry is preferred.
Must possess a strong working knowledge of US /EU regulations that affect Class III devices. Experience preparing domestic and international product submissions is preferred.
Must have strong English written and verbal communication skills, and have experience working on cross-functional projects.
Strong ability to problem-solve and apply analytical thinking is required.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 13,000 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.