Outstanding opportunity to be a part of one of the Medical Device Industry’s most groundbreaking technological innovations. Edwards is the only company to gain FDA approval for this revolutionary technology. In this role you will be part of a high performing Regulatory Affairs team that will be responsible for the regulatory process to support multiple products in the Percutaneous treatment of Aortic Valve disease.

Edwards has a strong pipeline in this space and the regulatory pathway is critical to getting these lifesaving products to our clinicians and patients. This business unit is expected to grow exponentially in the next 3 years and this role could be a significant stepping stone in your career. We are looking for individuals with 6+ years of experience in Medical Device RA, preferably in Class III devices and with exposure to PMA products.

For more information about the Transcatheter heart valve click on the following link:

http://www.edwards.com/products/transcathetervalve/pages/sapienthv.aspx

Job Description:

• Represent regulatory affairs on product development and commercialization teams related to Transcatheter Heart Valve products.
• Will monitor proposed and current global regulations and guidance, and will advise on impact of such regulations and guidance on the company within the scope of assigned project(s) as it relates to labeling and advertising.
• Responsible for regulatory review for claims support of promotional material, labeling content, product and process changes, and product documentation.

About Edwards:

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 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 about 7,000 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 help ensure that patients regain and even improve their quality of life.