As the Director, Regulatory Affairs, you will be responsible for ensuring the Global Leadership in Heart Valve Therapies boldly influences the creation of and meets the global regulatory requirements for the company’s emerging Transcatheter Mitral and Tricuspid Therapies initiative. You will interact with the FDA, Notified Bodies and other approval authorities as needed to develop the regulatory strategies for and manage all aspects of their execution for this novel therapy.
Collaborate on the development of the global regulatory strategy for transcatheter mitral and tricuspid therapies. Ensure the strategy’s implementation.
Partner with the R&D and Clinical Affairs departments in the development and implementation of Mitral and Tricuspid clinical and regulatory strategies to ensure pre-clinical and clinical trials meet appropriate regulatory requirements.
Interact with the FDA and other approval authorities to negotiate evidence needs, and facilitate global approval of an emerging technology. Manage all communications regarding transcatheter mitral and tricuspid therapies with all regulatory agencies; represent the company to agencies and trade associations.
Hire and develop the Regulatory Affairs team for this new mitral valve initiative; serve as a member of the leadership team for the initiative.
Facilitate new product development through a committed partnership with R&D, Manufacturing, Marketing and Clinical Affairs throughout all phases of the product development process.
Effectively manage the Regulatory Affairs team to ensure on-time submissions and approvals that support the mitral and tricuspid therapies initiatives.
A bachelor's degree in a related science or engineering discipline required. A related advanced degree is preferred.
Extensive knowledge of global regulatory for cardiovascular medical devices, including surgical and interventional devices required. Experience with heart valves, and experience with Nitinol implants, strongly preferred. Experience working in emerging therapeutic areas strongly preferred.
Proven track record of managing positive interactions with the FDA and other regulatory authorities, in addition to ensuring that standards of Edwards' communication and correspondence with regulatory bodies are maintained and documented.
Ability to operate effectively in a culturally diverse organizational structure, in addition to working independently with limited management oversight, is required.
Experience working globally and with global teams.
Possess a broad knowledge of surrounding areas including Quality, Clinical Affairs, Manufacturing and Development.
Internal Number: 010067
About Edwards Lifesciences
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 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.