Senior Specialist, Clinical Development

NO RELOCATION OR PhD CANDIDATES WILL BE CONSIDERED

On-Site, Irvine, California

8 Month Contract (May extend or convert to permanent)

$62/hour W2

Ensures product development includes all necessary clinical input and aspects for the best interest of patients and utility for treating physicians. This position serves as the primary bridge between engineering innovation and clinical application.

• Lifecycle Management: Lead product lifecycle management from early human use through commercial submission.
• Strategy Development: Implement pre-clinical test strategies and provide guidance to teams on execution.
• Scientific Rationale: Provide technical rationale for product attributes and pre-clinical test results.
• Design Control: Develop, review, and update clinical design control documents, including technical summaries, clinical risk assessments, Instructions for Use (IFU), and usability protocols.
• Risk Management: Apply FMEAs (Failure Modes and Effects Analysis) to technical and clinical documentation.
• Cross-Functional Leadership: Integrate procedural, medical, and scientific factors into project team meetings.
• Technical Training: Provide product expertise and introduction training for clinical and site personnel.
• Literature & Data Analysis: Conduct literature reviews for design concepts and analyze data to support clinical trial safety investigations and product evaluations.
• Field Consultation: Gather device performance feedback from field personnel to ensure national and international regulatory compliance.

• Bachelor’s Degree: Biology or Life Sciences field required;
  Engineering degree preferred.
• Professional
  
  Experience:
  
  5+ years in Class II and III medical device technologies or clinical studies background.
• Regulatory Knowledge: Comprehensive knowledge of US and international medical device regulations, Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
• Clinical Specialization: Experience in TMVR and/or fluoroscopic and echo cardiographic imaging preferred.
• Technical Proficiency: Expertise in MS Office Suite (Word, Excel, Project, PowerPoint) and Adobe.
• Clinical Knowledge: Familiarity with pre-clinical testing protocols, hospital environments, and sterile techniques.
• Analytical
  
  Skills:
  
  Strong data analysis capabilities with an understanding of statistical analysis techniques.
• Communication: Excellent written and verbal communication skills; strong consultative and relationship management abilities.
• Working Style: Thorough, conscientious, results-oriented, and team-oriented in a dynamic environment.
• Safety & Compliance: Strict adherence to company rules, pandemic protocols, and Environmental Health & Safety (EHS) standards.