Quality & Regulatory Affairs Manager
Medical Device Software / SaMD

Location: Gurugram, India
Work Model: In office | 5 days/week
Experience: 6–10 years
Reports to: Founder / CEO

About ImagingIQ
ImagingIQ is building AI-assisted medical imaging and radiology workflow solutions, with a focus on brain MRI oncology and expanding applications across CT, trauma, vascular, oncology and volumetric imaging.

About the Role
We are looking for a hands-on Quality & Regulatory Affairs Manager to establish and manage the quality and regulatory framework for our AI-enabled medical-device software.
The role will own QMS, regulatory execution, design controls, risk management, validation, audit readiness, CAPA and post-market quality processes, working closely with Product, Engineering, AI/ML, Clinical and Operations teams.
This is not a software-testing QA role. We are looking for someone with direct experience in medical devices / SaMD / digital health who can build practical quality and regulatory systems in a growing organisation.

Key Responsibilities




• Establish and maintain an ISO 13485-aligned Quality Management System (QMS).
• Develop and manage SOPs, document control, training, records, change control and quality governance.
• Conduct QMS and regulatory gap assessments and maintain implementation roadmaps.
• Manage CDSCO / Medical Devices Rules, 2017 requirements, product classification, licensing and regulatory submissions.
• Establish software design controls, lifecycle processes and end-to-end requirements traceability.
• Implement product risk-management processes aligned with ISO 14971.
• Ensure software development and validation processes align with IEC 62304 and applicable medical-device requirements.
• Partner with clinical, engineering and AI/ML teams on verification, validation, clinical/performance evidence and product claims.
• Establish controls for AI/ML data, model versioning, validation datasets and change impact.
• Own CAPA, non-conformances, complaints

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