Medical Device Regulatory Affairs Lead (Imaging Systems)

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...