Princiipal Regulatory Technical Documentation Engineer
: MDR & Regulatory Execution Own and produce MDR-required artifacts, including Design History Files (DHF), Technical...
: MDR & Regulatory Execution Own and produce MDR-required artifacts, including Design History Files (DHF), Technical...
' sleep and respiratory medical devices. Core Competencies Quality Management System (QMS) Design Controls (DHF, DMR... goals and objectives. Own the Design Control process (21 CFR 820.30), ensuring proper documentation of DHF, DMR, and DHR...
, ensuring alignment with design control and DHF requirements. Basic Qualifications: Bachelor’s degree in Packaging...
on cross-functional project teams, ensuring alignment with design control and DHF requirements. Basic Qualifications...
(DHF) for each project. Manages all aspects of assigned projects to ensure timely completion of tasks while remaining...
, ensuring alignment with design control and DHF requirements. Basic Qualifications: Bachelors degree in Packaging...
Packaging Engineering on cross-functional project teams, ensuring alignment with design control and DHF requirements... on cross-functional project teams, ensuring alignment with design control and DHF requirements. Employee Value Proposition...
of DHF and RMF. Maintain expertise in current and emerging requirements and quality trends for Pharmaceuticals, Medical...
submissions (INDs, IMPDs, BLAs) and responses to Health Authority inquiries as needed. · QA lead for Design History File (DHF...
, DHF DMR, Risk Management (FMEA), CAPA, Sustenance Engineering, Design Control Skills: Category Name Required Importance...