Edwards Lifesciences Manager, Regulatory Affairs Operations - Critical Care in Irvine, California
This is an outstanding opportunity to be a part of a forward-thinking regulatory affairs organization. The Manager, Regulatory Affairs will focus on supporting projects for our critical care sustaining products. We are looking for a diligent RA professional who works well across functional teams, takes initiative, and enjoys working in a fast-paced team environment.
Manage and oversee the work of team within country regulatory affairs and may indirectly manage cross functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department
Manage activities with the accountability for successful completion of all deliverables. Plan registration, labeling, pricing and reimbursement activities within agreed timeline in order to deliver licenses and to ensure regulatory compliance and market access
Develop in-country annual strategy on new product introduction pipeline and R&D budget forecast and management
Identify risk, develop and lead in the implementation of registration and labeling strategies which may include negotiations with internal and external parties
Other incidental duties
Education and Experience:
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
A demonstrated track record in people management is required
Experience working in the medical device industry is required
Proven successful project management leadership skills
Proven expertise in both Microsoft Office Suite 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
Good presentation skills
Excellent English skills
Expert understanding of regulatory affairs procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
Expert understanding of related aspects of product lifecycle processes and Edwards Ignite system and government regulatory systems
Knowledge of global cross functional teams and how to interact e.g. labeling business units, marketing, regulatory affairs, quality functions
Knowledge of financial mechanism that relates to budget forecast and profit & loss
Demonstrated ability to manage assigned team 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
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 work and excel within a fast paced, dynamic, and constantly changing work environment
Frequently interacts with customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company; often leads a cooperative effort among members of a project team
Participate and present at meetings with internal and external representatives
Resolve operational and scheduling issues
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.
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.