Edwards Lifesciences Manager, Regulatory Affairs Program Management - Critical Care in Irvine, California
This is an excellent opportunity to join a high growth, innovative and industry-leading organization and advance a career in the Regulatory Affairs function. As a Manager, you will represent regulatory affairs on a variety of product development teams related to Critical Care products and as an individual contributor, guide teams to provide content for US and/or International submissions and participate in design reviews as needed. You will also prepare document packages for submission to global regulatory agencies, IDEs, 510(k)s and CE marking design dossiers, technical files and international design dossiers and change notifications.
Monitor proposed and current global regulations and guidance; advise on impact of such regulations and guidance on the company within the scope of assigned project(s).
Will interact directly with Regulatory Agencies under management guidance.
Responsible for regulatory promotional material, labeling content, product and process changes, and product documentation; analyzes and recommends appropriate changes.
Participate as an active member of the EU MDR transition team.
Communicate and maintain productive constructive relationships with Edwards Lifesciences external customers as required – US FDA, distributors, third-party in-country regulatory representatives, and notified bodies.
Keep direct manager apprised of activity status and participate as an integral team member of the RA team.
Perform other duties as assigned by RA leadership.
A bachelor’s degree in a related field is required; a scientific discipline is preferred.
A minimum of ten years of related experience is required with a bachelor’s degree, OR, a minimum of eight years of related experience is required with a master’s degree.
Clinical experience or experience in regulatory support of clinical studies (significant risk and non-significant risk) is preferred.
Experience with IDEs, PMAs and/or 510(k) medical device products is required.
Experience writing FDA submissions required.
Strategic thinking and problem-solving capabilities is required.
Ability to influence others at all levels of the organization is essential.
Well-versed in program and project management, and new product development best practices.
Project management certification is a plus.
Direct and matrix supervisory experience a plus.
Requires the ability to travel 20% of the time (domestic)
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.