Sr Specialist, Regulatory Affairs - Transcatheter Mitral & Tricuspid Therapies
July 30, 2018
Full Time - Experienced
4 Year Degree
The Sr., 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.
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 minimum of 5 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.
Internal Number: 014032
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.