Edwards Lifesciences

Key Responsibilities: • Manage and/or lead a small team within the assigned function including team budget responsibilities and managing outside contractors/vendors. Oversee the conduct of the internal clinical operations team including management of performance metrics, effectiveness, LMS compliance, CTMS completeness and TMF quality. Develop team members to increase business acumen and functional skills. Collect performance feedback of assigned staff from

Ensure trial patients’ safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence. Key Responsibilities: • Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis,

Completes and maintains regulatory approvals and clearances of assigned products. Key Responsibilities: • Represent the regulatory function on manufacturing and product development teams as a subject matter expert (SME) to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues; also recommends multiple solutions for selection by management. Prepare

Job Description / Responsibilities: This position is an integral part of the Transcatheter Heart Valve Finance team in Irvine supporting financial planning, forecasting, accounting and reporting activities. Additionally, the position will contribute to the preparation of executive presentations and perform insightful analyses during key planning processes. A successful candidate will demonstrate the ability to build strong and trusting business partner

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. For more than 50 years, we have established a remarkable track record around that innovation: Work that enables clinicians around the world to enhance and save lives. Edwards is looking for a Program Manager. In this role, you will

The Senior Regulatory Affairs Specialist will focus on supporting US and EU submissions. This opportunity presents a unique opportunity to lead the way in the Transcatheter Mitral and Tricuspid Therapies and cutting-edge technology. Responsibilities: Represent regulatory affairs on product development and commercialization teams related to TMTT. Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic

Manage all Regulatory Affairs activities within the respective country / countries Key Responsibilities: • Develop and plan multiple complex and/or advanced regulatory affairs projects and activities including analysis of situations or data requiring an evaluation of intangible variables with accountability for successful completion of all project deliverables. May include representing the regulatory function on manufacturing and product development teams to