Edwards Lifesciences Mgr, Regulatory Affairs in Shanghai, China
Manage all Regulatory Affairs activities within the respective country(ies).
• Plan registration, labeling activities with accountability for successful completion within agreed timeline in order to deliver licenses and to ensure regulatory compliance and market access
• Provide direction and guidance to other team members (if any) to execute tactical registration and labeling initiatives
• Identify and evaluate registration, labeling and build process improvements and course correction/course alignment opportunities
• Analyze local regulatory trends and market intelligence information; advise and make recommendations to International RA team on the potential high impact risks and change implementation
• Develop solutions on regulatory issues and present to both internal and external parties
• Analyze information on product recalls from field corrective action team (EW global quality team) and provide reports to government.
• Other incidental duties
Education and Experience:
Bachelor's Degree or equivalent in in related field , 8 years years experience of previous related experience Required or
Master's Degree or equivalent in in related field , 6 years years experience of previous related experience Required
Other: Experience working in a healthcare company Required
• Proven successful project management skills
• Proven expertise in both Microsoft Office Suite, including advanced Word, Excel and government regulatory systems
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Fluent in reading, writing and speaking English
• Extensive knowledge of regulatory affairs within the organization while contributing to the development of new concepts, techniques, and standards
• Extensive understanding of related aspects of product lifecycle processes and Edwards Ignite system and government regulatory systems
• Extensive knowledge of Edwards products
• Knowledge of healthcare industry
• 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 manage competing priorities in a fast paced environment
• Represents leadership on sections of projects within a specific area interfacing with country management teams (e.g. Business Unit head, Quality head, Ops head, Finance head)
• Consult in project setting within specific sections of regulatory affairs area
• Provides leadership to outsourcing partners of regulatory affairs consulting companies (e.g. on registration, labeling) on special projects
• 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 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.