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...
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...
and mentorship to junior staff or specialists on assigned project Requirements: Bachelor's degree in Regulatory Affairs, Life... Sciences, Engineering, or a related field. 4-6 years of regulatory affairs experience in the medical device or IVD industry...
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...
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...
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...
Job Description: We are looking for a Project Manager with a strong understanding or prior experience in Packaging Technology to lead projects focused on cost savings, sustenance, and Value Engineering / Value Analysis (VE/VA). This role c...
Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key m...
solutions tailored exclusively for the dynamic life science industry. We provide a full spectrum of services, including...