JOB DESCRIPTION
Quality & Regulatory Affairs Manager
Medical Device Software / Software as a Medical Device (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. Our current work centres on brain MRI oncology and is expanding into brain CT, trauma, vascular, oncology and volumetric applications. The platform processes medical images, produces structured AI-assisted outputs and integrates with radiology workflows while keeping qualified clinicians responsible for review and final reporting.

The role
We are looking for a hands-on Quality & Regulatory Affairs Manager to establish and operate a practical, scalable quality-management and regulatory framework for AI-enabled medical-device software. You will serve as the company’s primary working owner for QMS and regulatory execution, partnering closely with the Founder/CEO, Practice Head, product, engineering, data science, clinical and operations teams.




This is not a conventional software-testing QA position. The role owns the quality system, regulatory strategy, design and risk traceability, audit readiness, submission support, clinical and performance evidence processes, supplier quality, CAPA, complaints and post-market quality processes. You should be comfortable building fit-for-purpose systems in a growing organisation, not only maintaining procedures created by a large established quality department.
Core mandate: Create the quality and regulatory operating system that allows ImagingIQ to develop, validate, release and support medical-device software responsibly in India and prepare for future international markets.

What you will own
Conduct a structured regulatory and QMS gap assessment and maintain a phased 90-day, 180-day and 12-month roadmap aligned with product releases, clinical deployment and business priorities.
Establish, implement and continuou

📌 Quality and Regulatory Manager (Gurugram)
🏢 Imaging IQ
📍 Gurugram