Edwards Lifesciences LLC

  • California, USA
Edwards Lifesciences LLC Remote * (California, USA)
Sep 16, 2021
Full-Time
Edwards has an exciting opportunity in the Critical Care group, focused on transforming patients' lives by advancing Critical Care innovations. As Senior Specialist in this role, you will work closely with Regulatory, Quality, R&D, and Clinical professionals and other subject matter experts to create Clinical Evaluation Plans and Reports (CEP, CER, respectively) to support EU MDD and MDR requirements. These reports will be included in the respective technical documentation file to support initial and continued CE Marking and must effectively and clearly describe research results, literature searches and reviews, product use and other required information. You will also ensure that the documents and presentations comply with MED DEV 2.7.1, rev 4 as well as MDD, MDR, and internal processes in terms of content, format and structure. Job Functions: Support regulatory submissions and other associated activities by authoring CEP's and CER's or providing input from the CER into...
Edwards Lifesciences LLC Remote * (California, USA)
Sep 08, 2021
Full-Time
This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. The candidate will join a fast-paced, dynamic team and the individual who fills it will play a pivotal role in the development of new therapies and devices, from concept through to human use. Key Responsibilities include but are not limited to: Drive data standards implementation by ensuring technical quality compliance in alignment with industry standards (e.g., CDISC) and regulatory guidance, consistency in the adoption of data standards across clinical systems and provide technical guidance for study teams Provide functional expertise to clinical data standards solutions, and lead the activities clinical data standards solutions to support data collection, reporting, and submission Lead the maintenance of the clinical standards library components and...