Edwards Lifesciences Director, International Regulatory Affairs - Transcatheter Mitral and Tricuspid Therapies in Irvine, California
The Director, International Regulatory Affairs is responsible for managing the International Regulatory Affairs team and activities within the respective country(ies).
Key responsibilities include the following:
Direct activities through several managers, with overall responsibility of developing systems, planning, staffing, budgeting, managing expense priorities, recommending and implementing changes to methods. Develop a robust talent development and succession planning in alignment with functional growth strategies across regional regulatory affairs
Plan and direct strategic activities including prioritizing and selecting appropriate projects with overall responsibility for meeting business objectives. Lead in identifying risk, developing complex mitigation strategies, best practices, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams
Mitigate/eliminate risk, direct and communicate highly complex regional regulatory affairs strategies which includes negotiations with internal and external parties
Analyze, formulate and present recommendations related to regional regulatory affairs to advise and guide executive level leadership; develop and deliver executive level communication
Other incidental duties
Education and Experience:
A Bachelor's degree in related field is required; A scientific discipline is preferred
A Master's degree or equivalent in a related field is preferred
Demonstrated track record in people management is required
Medical device regulatory affairs experience is required
Proven successful project management leadership skills
Proven expertise in Microsoft Office Suite and related tools and government regulatory systems
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Excellent influencing and presentation skills
Fluent in reading, writing and speaking English
Expert understanding of regulatory affairs procedures while looking beyond existing methodologies and own discipline to define and resolve complex problems
Expert understanding of related aspects of regulatory affairs processes and/or systems
High level of knowledge of financial mechanism that relates to regulatory affairs
Demonstrated ability to direct teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of regulatory affairs to the business
Serve as core partner to senior leaders in Business Units, Functional Groups, Regions and IT
Strict attention to detail
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
Interacts with senior management, and others concerning matters of significance to the company
Conduct business and technical briefings for senior and top management and for external representatives
Regularly interacts with executives and/or major customers; interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization
Dedicated to quality client service and pro-active and responsive to client needs.
Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
Provide leadership and direction to large cross-functional teams to successfully implement global enterprise systems and related solutions
Develop relationships and leverage them to influence change
Support and solicit input from team members at all levels within the organization
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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.