This is an excellent opportunity to join a high growth, innovative and industry leading organization and advance a career in the Regulatory Affairs function. The Associate Manager, Project Management Regulatory Affairs THV will initiate, plan, execute and manage multiple Regulatory Affairs project(s) to ensure ultimate project success.
Determines and discerns detailed requirements on larger scale projects to establish the project deliverables, and manages changes to the project scope, schedule, and costs to keep the project management plan updated and reflective of authorized project changes.
Establishes and maintains team members and project stakeholder relationships, expectations, and communications.
Measures project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify variances, perform required corrective actions, and communicate to all stakeholders.
Executes and leads the execution of tasks as defined in the project management plan in order to achieve the project goals, and actively manages project risk.
Manages project closure activities, including gathering lessons learned.
Serves as a project management subject matter expert, Keep Regulatory Affairs leadership abreast of project schedules and potential areas of conflict/concerns or delays.
Bachelor’s degree required. A degree in Biomedical Engineering, another Engineering discipline, Marketing, or a Science is strongly preferred.
Requires a minimum of 5-8 years experience.
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.
Proven expertise in usage of MS Office Suite and related project management systems.
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
Proven record of delivering business impact.
Internal Number: 013648
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.