Clinical Development Specialist

 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.

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.

How you’ll make an impact:

• 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 projects, including:
• Develop and implement pre-clinical test strategy and provide guidance to team members on strategy execution
  Design, prepare and conduct first-in-man product evaluations, including case support for proper product use
• Create Clinical Investigator Brochure
• 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 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 moderately complex 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.
• Evaluate collected data documentation and imaging media, draw findings, and make recommendations to complete product evaluations, product complaint review and other required interim or final reports.
• Consult with field trial managers to gather field device performance feedback, as well as to ensure national and country clinical/regulatory requirements compliance.
• This role will require 25% travel nationwide.
• This is an on site position located in Irvine, Ca.
   

What you'll need (Required):

• Bachelor's Degree in biological or Lifesciences field, 3 years experience previous related experience in 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 in MS Office Suite, Adobe, and ability to operate general office machinery; Experience with documentation management systems (e.g., Ignite) preferred
• Excellent written and verbal communication skills and interpersonal relationship skills
• Demonstrated problem-solving and critical thinking skills
• Moderate knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies
• Moderate understanding of pre-clinical testing protocols, hospital environments and sterile techniques
• Moderate knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects
• Ability to build productive internal/external working relationships
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Healt