Job Description
Job Title:
RA & QA Engineer – Regulatory & Safety (Radiology & Imaging Systems)
Department:
Regulatory & Safety – Radiology Division
Location:
Vapi, Gujarat
Reports To:
Manager / Senior Manager.
Job Purpose:
To manage and coordinate
regulatory documentation and compliance activities
for
radiology and imaging systems
such as
X-Ray, C-Arm, Digital Radiography (DR), and CT equipment , ensuring adherence to
BIS, AERB, NABL , and international regulatory standards applicable to medical device manufacturing.
Key Responsibilities:
1. Regulatory Documentation and Compliance
Prepare, review, and maintain documentation for product approvals and certifications from
BIS (Bureau of Indian Standards), AERB (Atomic Energy Regulatory Board), and NABL (National Accreditation Board for Testing and Calibration Laboratories).
Ensure all technical files, QA test reports , and compliance certifi...
RA & QA Engineer – Regulatory & Safety (Radiology & Imaging Systems)
Department:
Regulatory & Safety – Radiology Division
Location:
Vapi, Gujarat
Reports To:
Manager / Senior Manager.
Job Purpose:
To manage and coordinate
regulatory documentation and compliance activities
for
radiology and imaging systems
such as
X-Ray, C-Arm, Digital Radiography (DR), and CT equipment , ensuring adherence to
BIS, AERB, NABL , and international regulatory standards applicable to medical device manufacturing.
Key Responsibilities:
1. Regulatory Documentation and Compliance
Prepare, review, and maintain documentation for product approvals and certifications from
BIS (Bureau of Indian Standards), AERB (Atomic Energy Regulatory Board), and NABL (National Accreditation Board for Testing and Calibration Laboratories).
Ensure all technical files, QA test reports , and compliance certifi...
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