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Senior Manager, Clinical Safety – Transcatheter Mitral & Tricuspid Therapies

Company Name: Edwards Lifesciences LLC
Location: Irvine, CA
Job Type: SEE/Full-Time
Contact Name: Mimi Ornelas
Email: Apply directly online (see below)

Job Description: 

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 support of new therapies and devices, from early through to human use through commercialization. 

  • Manage and oversee the work of clinical safety and may have financial budget responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department. Provide input to clinical safety strategies within Business Unit
  • Oversee the development and ensure alignment of safety processes (e.g., safety work instructions and related documents, SOPs, charters) as needed. Identify risk, develop and lead in the implementation of broad and more complex clinical safety strategies which may include negotiations with internal and external parties  

Job Requirements (up to 200 words): 

  • Bachelor's Degree in related field with 12 years previous related experience; or Master's degree in related field with 10 years of previous related experience required
  • Experience in Medical device or pharmaceutical industry, Clinical research, or in-hospital clinical and/or managerial experience preferred
  • Proven successful management skills
  • Proficient in Microsoft Office Suite and related tools and systems
  • Excellent writing and communication skills
  • Excellent interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
  • Ability to travel up to 15-20%  

Please apply online at: