Regulatory & QA Engineer - Radiology
Core
Manage regulatory documentation and compliance for radiology and imaging systems (X-Ray, C-Arm, DR, CT) to ensure adherence to BIS, AERB, NABL, and international standards.
Role type
Regulatory & QA Engineer (Medical Devices)
Builds
Regulatory compliance for medical imaging equipment
Domain
Medical device manufacturing / Radiology
Deliverable
client delivery
Required skills
Regulatory documentation management, Technical file preparation, Audit coordination, Cross-functional collaboration, Version control, Compliance reporting
Preferred skills
Knowledge of ISO 13485, BIS 13450, IEC 60601, ISO 17025
Technologies
None stated
Responsibilities
Prepare and maintain documentation for product approvals and certifications, Ensure manufacturing and testing processes comply with regulatory standards, Liaise with regulatory bodies and certification agencies, Manage regulatory documentation databases and document traceability, Support internal and external audits, Collaborate with Design, Quality, and Production teams
Seniority
Individual Contributor