Sr. Manager, International Regulatory Affairs - Transcatheter Mitral &Tricuspid Therapies
September 25, 2018
Full Time - Experienced
Coordination and management of Edwards Regulatory Affairs activities for the Transcatheter Mitral and Tricuspid Therapies (TMTT) Business Unit. Ensure compliance of Edwards’ products with regulatory requirements. Management of the communication and relationship with local authorities.
Primary Job Functions:
Define and execute Regulatory strategies for international pre-approval clinical studies, post-approval clinical studies and international commercialization in collaboration with in-country counterparts.
Provide Regulatory strategic direction and coordination for TMTT international product launches.
Provide subject matter expertise and/or leadership to TMTT RA organization on international Regulatory requirements including European, Japan / Asia Pacific, and Latin America.
Represent TMTT Regulatory Affairs on Edwards Corporate initiatives.
Deliver project/change management expertise, strategic planning, and implementation support for key TMTT RA organizational initiatives.
Drive continuous improvement & innovation within the TMTT RA function.
Management Regulatory Affairs aspects of ‘product holds’ and field corrective actions for TMTT product portfolio.
Represent TMTT Regulatory Affairs on a variety of global regulatory initiatives and provide regulatory guidance to the TMTT Business Unit.
Enhance and strengthen the communication processes between International RA and the Business Unit Regulatory Affairs team.
The ideal candidate will be able to evaluate global directives, assess the ramifications to Edwards’ business and develop regulatory solutions. He/she will work closely with the regulatory teams across the regions for all products within the TMTT portfolio.
Advanced Degree or country equivalent in science-related field.
Minimum 10+ years in medical device and pharmaceutical industry with increasing levels of expertise/experience
Established understanding of registration processes and their inter-dependencies and a demonstrable track record of driving regulatory strategic and operational excellence.
Expert knowledge of regulations, current industry practices, and strong experience with interpretation and application of regulatory guidelines pertinent to a diverse drug/device portfolio.
Established credibility with regulatory authorities and other external stakeholders and understanding and translation of regulatory trends into actionable opportunities.
Excellent written and verbal communication, presentation, and facilitation skills
Internal Number: 013854
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.