Edwards Lifesciences Senior Manager, Regulatory Affairs-Forecasted Opening in Irvine, California
Title: Sr. Manager of Regulatory Affairs- Forecasted Opportunity
This position has been posted in anticipation for future openings within Regulatory Affairs. If you meet the minimum requirements, you will receive additional information about our Regulatory Teams.
The Senior Manager, Regulatory Affairs generally represents the RA function on a variety of Product Development Teams with a goal of commercializing a new and innovative technology for Class II or Class II products. They develop a variety of solutions to regulatory challenges and will exercise independent judgment in determining appropriate regulatory action and requirements for product changes and preparation of regulatory documents. He/she may interact directly with Regulatory Agencies under management guidance.
Key activities potentially include:
Represent regulatory affairs on product development and commercialization
Interacts with FDA and/or other regulatory bodies for submissions and projects
Will monitor proposed and current US and EU regulations and guidance
Responsible for regulatory review for claims support of promotional material, labeling content, product and process changes, and product documentation.
Prepares document packages for submission to global regulatory agencies (IDEs, PMAs, annual reports, 510(k)s and CE marking design dossiers and technical files). Prepare IDE and PMA annual reports and Justifications to File.
Requires a bachelor’s degree with 12 years industry experience and 5 years direct RA experience or master’s degree with 10 years industry experience and 4 years direct RA experience or Ph.D. plus 8 years industry experience with 3 years direct RA experience
Experience with Class II and Class III devices; a strong understanding of global regulations; excellent writing and verbal communication skills; and strong problem-solving and analytical ability
Experience in preparing domestic FDA and EU product submissions required
Requires familiarity with new product development systems; a strong working knowledge of all U.S. regulations that affect
Experience managing and developing others
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 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.