The Senior Manager, Regulatory Affairs role represents an excellent opportunity to join a high growth, early-stage product development group, Transcatheter Mitral and Tricuspid Therapies (TMTT) focused on developing solutions for patients suffering from structural heart disease. This is a unique position to advance a career in the Regulatory Affairs function with an industry leading organization. The successful candidate will represent the RA function on a variety of Product Development Teams with a goal of commercializing a new and innovative technology.
The candidate we seek will demonstrate the ability to 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.
Represent regulatory affairs on product development and commercialization teams related to Transcatheter Mitral and Tricuspid Therapies.
Interacts with FDA and/or other regulatory bodies for submissions and projects.
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 on RA strategy for US IDE, US PMA, CE Trial, CE Mark, as required.
Additional Responsibilities will include:
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.
Assume regulatory review of promotional material, labeling content, product and process changes and product documentation.
Act as liaison with government officials in support of product approvals.
Work on multiple projects where analysis of situations or data requires an evaluation of intangible variables.
May work on new/emerging technology that has no or limited history.
Demonstrate the ability to develop a variety of solutions to regulatory challenges.
Exercise independent judgment in determining appropriate regulatory action and requirements for new product or product changes and preparation of regulatory documents.
Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Ensure schedules and performance requirements are met. Erroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.
Requires a minimum of twelve years’ experience in Regulatory Affairs. Medical device experience in other areas, may be considered.
Experience in preparing domestic FDA and EU product submissions required.
A Bachelor’s degree is required, preferably in a scientific discipline.
Demonstrated competence in working as part of a focused, project team.
Demonstrated competence in determination of appropriate global regulatory requirements for new products or product changes.
Demonstrated understanding of basic regulatory requirements for promotional materials.
Experience in review and approval of promotional materials is a plus.
Requires familiarity with new product development systems; a strong working knowledge of all U.S. regulations that affect.
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.
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, Californi...a, 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.