Senior Specialist, Clinical Development

Edwards Lifesciences seeks a Senior Specialist in Clinical Development to oversee clinical input and product lifecycle management for transcatheter heart valve technologies. The role involves designing clinical strategies, conducting evaluations, preparing regulatory documentation, and ensuring compliance with medical device standards.

Responsibilities

• Develop and implement pre-clinical test strategies and conduct first-in-man product evaluations
• Design clinical trial strategies and create Clinical Investigator Brochures
• Develop clinical design control documents and provide technical/clinical guidance to product teams
• Conduct literature reviews and post-market evaluations; assess results and provide recommendations
• Ensure medical and scientific considerations are incorporated in cross-functional product development meetings

Requirements

• Bachelor's degree in biology or life sciences; 5+ years with Class II/III medical devices or clinical studies
• Proficiency in Microsoft Office Suite, Adobe, and general office software
• Knowledge of US and international medical device regulations, GLP, and GCP
• Experience with pre-clinical testing protocols and sterile techniques
• Strong written and verbal communication and interpersonal skills
• Demonstrated problem-solving and critical thinking abilities
• Willingness to travel up to 50% nationwide

Compensation: $108,000-$153,000 base