Sr Specialist, Clinical Development

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

 How you’ll make an impact:

• This position is on site in Irvine, Ca with travel up to 25% nationwide.

  Ensures product development includes all necessary clinical input and aspects for the best interest of patients and utility for treating physicians.
• Ensure successful product lifecycle management for multiple complex projects, including:
• Develop and implement pre-clinical test strategy and provide guidance to team members on execution strategy
• Design, prepare and conduct first-in-man product evaluations, including case support for proper product use
  Create Clinical Investigator Brochure
• Develop clinical trial strategy
• Provide scientific rationale for product attributes and pre-clinical test results to regional clinical teams necessary to obtain site and country approvals
• Provide product expertise for new product introduction training for clinical and site personnel
• Design, develop, conduct, and assess results of post-market evaluations
• Develop, review, and update clinical design control documents including providing advice and guidance to product development team on development of technical summaries, clinical risk assessments, design of validation protocols and reports, design and application of FMEAs (Failure Modes and Effects Analysis), for technical and clinical documentation in product development.
• Ensure medical and scientific factors are considered during cross-functional product development project team meetings.
• Design, review and/or conduct literature searches and complete literature reviews for design concept, product development, protocol preparation, clinical risk assessments and/or clinical evaluation reports
• Consult with field trial managers to gather field device performance feedback, as well as to ensure national and country clinical/regulatory requirements compliance.
• Evaluate collected data documentation and imaging media, draw findings, make recommendations, and provide advice and guidance to complete product evaluations, product complaint review and other required interim or final reports.
   
   

What you'll need (Required):

Bachelor's Degree in biology or life Sciences field, with 5 Years experience Class II and III medical device technologies and/or clinical studies background Required

What else we look for (Preferred):

• Bachelor's Degree in engineering Preferred
• Proven expertise with computer skills – Microsoft Office (Word, Excel, Project, PowerPoint), Outlook, Internet
• Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery
   
• Experience with pre-clinical testing protocols, hospital environments and sterile techniques
• Good communication and organizational skills
• Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills
• Full knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
• Demonstrated problem-solving and critical thinking skills
• Thorough, conscientious and results oriented working style
• Team oriented
• Ability to work in a dynamic work environment
• Knowledge of US/international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well a