Posted:2 weeks ago|
Platform:
Work from Office
Full Time
Job Title: QARA ENGINEER
Experience: 4.5 to 10 years
Location: Bangalore
Mandatory Skill: US FDA, 510K, PMA, EU MDR, QARA. Regulatory gap assessment and remediation.
Job Description:
The objective of this project is to identify and remediate any deficiencies in the design history files (DHF) and device master records (DMR) of the stent graft integrated with 4 branched vascular prosthesis - FROZENIX 4 Branched, ensuring adherence to relevant standards, US Food and Drug Administration ("FDA") guidelines and regulations requirements by completing all necessary tasks including document translation (Japanese to English), gap assessment, remediation and submission query support.
Larsen & Toubro (L&T)
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