5.0 - 10.0 years

0 - 1 Lacs

Bengaluru

Work from Office

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. Design verification and Validation US FDA 510k submission process US FDA Premarket approval ISO 14971 - Medical device risk management DHF Gap assessment DMR Gap assessment EU MDR 2017/745 regulations CE Technical documentation Technical standards and guidance (for medical device) ISO 60601 Electrical safety IEC 62304 - Human factors and Usability engineering ISO 10993 - Biocompatibility testing

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