QMS

Job Description:<br /> 8+ years of experience in Business Analysis, Quality Assurance, or Regulatory Affairs within the medical device industry<br /> Minimum 5 years of direct involvement in QMS implementation, documentation, or compliance activities for regulated medical devices<br /> Experience working on Class II or Class III medical device programs in FDA and/or EU regulatory environments<br /> Exposure to SaMD (Software as a Medical Device) or connected device programs is advantageous<br /> Technical Standards Knowledge<br /> ISO 13485 2016 - Working knowledge; experience applying requirements across QMS processes<br /> 21 CFR Part 820 - Familiar with FDA QSR structure, design controls, and DHF expectations<br /> EU MDR 2017/745 - Basic to intermediate understanding; experience contributing to Technical Files<br /> IEC 62304 - Exposure to software lifecycle documentation and classification<br /> IEC 82304-1 - Awareness of...