Manager, Regulatory Affairs - Transcatheter Mitral and Tricuspid Therapies
September 25, 2018
Full Time - Experienced
4 Year Degree
The Manager, Regulatory Affairs 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 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.
Additional Responsibilities may include:
Prepares document packages for submission to global regulatory agencies (ie, IDEs, PMAs, annual reports, 510(k)s and CE marking design dossiers and technical files).
Prepare IDE and PMA annual reports as well as 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.
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.
Manage and mentor more junior members of the Regulatory Affairs team.
Requires a minimum of ten years experience in Regulatory Affairs. Medical device experience in other areas may be considered.
Experience in developing new product registration/dossiers for domestic FDA and EU product submissions is required.
A Bachelors 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.
Experience in review and approval of promotional materials is a plus.
Experience in the cardiovascular device space is highly desirable.
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.
Internal Number: 014836
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.