The Senior Manager, Regulatory Affairs Program Management role represents an excellent opportunity to join a high growth, innovative and industry leading organization and advance a career in the Regulatory Affairs function. The successful candidate will represent the Regulatory Affairs function on a variety of Manufacturing and New Product Development Teams related to our exciting and leading-edge Transcatheter Heart Valve business. These projects generally have durations ranging from months to years.
US and European regulatory affairs with some interface with global partners
Determining regulatory paths for new product development, product and process change control
Writing and/or submitting technical documents including 510(k)s, IDEs, PMAs, CE Technical Files/Dossiers and clinical trial protocols/updates
Provide regulatory review/approval of labeling and act as liaison with FDA and the Notified Body in support of product approvals
Support project teams with global regulatory strategies
Provide review and input of protocols and reports for: design verification, design validation, process qualifications, biocompatibility studies, shelf life, pre-clinical studies, animal studies, and clinical studies
Monitor, research, and obtain information on FDA activities and proactively share information within Edwards - Effectively communicate with regulatory agencies
A Bachelor’s degree is required; a scientific discipline is preferred
Requires a minimum of twelve (12) years of related experience with a Bachelor’s degree, or ten (10) years of related experience with a Master’s degree
Excellent written and verbal communication skills
Experience working on cross-functional project teams
Expert knowledge of all U.S. regulations that affect Class II and III devices
Expert knowledge of European regulatory requirements for Class IIa/b/III devices
Basic understanding of other global regulations
Strong problem-solving and analytical ability
Internal Number: 016750
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.