Job Description
Job Description:
8+ years of experience in Business Analysis, Quality Assurance, or Regulatory Affairs within the medical device industry
Minimum 5 years of direct involvement in QMS implementation, documentation, or compliance activities for regulated medical devices
Experience working on Class II or Class III medical device programs in FDA and/or EU regulatory environments
Exposure to SaMD (Software as a Medical Device) or connected device programs is advantageous
Technical Standards Knowledge
ISO - Working knowledge; experience applying requirements across QMS processes
21 CFR Part 820 - Familiar with FDA QSR structure, design controls, and DHF expectations
EU MDR 2017/745 - Basic to intermediate understanding; experience contributing to Technical Files
IEC 62304 - Exposure to software lifecycle documentation and classification
IEC 82304-1 - Awareness of health software requirements
IEC 62366-1 - Familiarity with us...
8+ years of experience in Business Analysis, Quality Assurance, or Regulatory Affairs within the medical device industry
Minimum 5 years of direct involvement in QMS implementation, documentation, or compliance activities for regulated medical devices
Experience working on Class II or Class III medical device programs in FDA and/or EU regulatory environments
Exposure to SaMD (Software as a Medical Device) or connected device programs is advantageous
Technical Standards Knowledge
ISO - Working knowledge; experience applying requirements across QMS processes
21 CFR Part 820 - Familiar with FDA QSR structure, design controls, and DHF expectations
EU MDR 2017/745 - Basic to intermediate understanding; experience contributing to Technical Files
IEC 62304 - Exposure to software lifecycle documentation and classification
IEC 82304-1 - Awareness of health software requirements
IEC 62366-1 - Familiarity with us...
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