standards (e.g., ICH-GCP, CDISC). Requirements: Bachelor's degree in a life science, health science, pharmacy, public health...
Roles & Requirements: 5+ Years' experience in medical device V&V for a large company. Experience with FDA-regulated V&V. IEC 62304 experience. Meaningful direct experience in writing verification protocols, executing protocols, and...
Job Description: Seeking a Quality Engineer with experience in manufacturing processes, process validation, CAPA, and medical devices. Responsible for ensuring compliance with quality standards, supporting validation activities, and drivin...
Responsibilities: Regulatory / V&V / Quality Assurance Engineer with 10-14 Years of experience. Bachelor of Engineering / Diploma' in Mechanical or equivalent. Knowledge of Design History file, Device History Record and Device Master Re...
Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Cr...
Job Description: Seeking a Quality Engineer with experience in manufacturing processes, process validation, CAPA, and medical devices. Responsible for ensuring compliance with quality standards, supporting validation activities, and drivin...
Responsibilities: Regulatory / V&V / Quality Assurance Engineer with 10-14 Years of experience. Knowledge of Design History file, Device History Record and Device Master Record documents. Proficiency in Project management and execution....
Responsibilities: This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA and EU regulation...