Job Summary The CVS Lead is responsible for leading Computer System Validation activities for GxP-regulated systems to ensure compliance with global regulatory standards. The role involves managing validation lifecycle activities, coordina...
Responsibilities: Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelin...
Job Description This person is going to be helping design an assembly line - calculating Demand at Capacity, building excel files to calculate # of stations needed, reviewing OMS/work content to potentially combine work stations, manipulat...
Responsibilities: Support the IVDR project by revising the assigned technical files. Each technical file must be generated using the latest technical file template and it must clearly present the product, its characteristics and its expec...
Job Summary: Support quality engineering initiatives across supplier quality, manufacturing, and quality systems. Ensure products meet regulatory, customer, and internal quality requirements through effective process controls, CAPA execu...
Roles & Responsibilities : Perform routine & specialized laboratory testing following GMP/cGMP guidelines Experience with instrument calibration, qualification & basic troubleshooting Prepare reagents and manage lab inventory & supplies...
Responsibilities: Provides SAS programming support to all clinical studies. Manages assigned programming CROs providing oversight and appropriate QC for programming deliverables. Provide statistical programming support for regulatory su...
Job Description: Quality Control (QC) of in-house components: Develop inspection protocols, control charts, validate measurement equipment. New Product Introductions & Corrective Actions: Lead cross-functional teams, troubleshoot manufactu...
Responsibilities: The Associate Regulatory Affairs Manager will support the development, review, and submission of regulatory documents for medical device and IVD products. This role will assist in managing regulatory projects, ensuring ...
Job Description: The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individu...