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Job details:
Quality & Regulatory Affairs Manager
Medical Device Software / SaMD
Location: Gurugram, India
Work Model: On-site | 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, audits and post-market quality processes.
- Manage supplier and partner quality requirements.
- Coordinate with regulatory bodies, certification bodies, notified bodies and external QARA partners.
- Support preparation for future international regulatory pathways, including FDA.
- Train cross-functional teams on quality and regulatory requirements.
Required Qualifications
- 6–10 years of relevant experience in Quality, Quality Systems or Regulatory Affairs.
- Direct experience in medical devices, medical-device software, SaMD or digital health.
- Hands-on experience with an ISO 13485-based QMS.
- Practical experience with CDSCO / Indian medical-device regulations and the Medical Devices Rules, 2017.
- Working knowledge of ISO 14971 and IEC 62304.
- Experience with design controls, risk traceability, verification/validation and change control.
- Experience with CAPA, internal audits, regulatory inspections and quality documentation.
- Strong ability to work with software engineering, AI/ML, clinical and product teams.
- Strong documentation and communication skills.
- Bachelor's or Master's degree in Engineering, Pharmacy, Life Sciences, Biomedical Sciences, Quality Management, Regulatory Affairs or a related field.
Preferred Experience
- AI/ML-enabled medical devices
- Medical imaging / radiology software
- PACS / RIS / DICOM
- FDA 510(k) / De Novo
- 21 CFR Part 820 / QMSR
- IMDRF SaMD guidance
- Clinical/performance evaluation
- Medical-device cybersecurity
- eQMS implementation
- Experience building QARA processes in a startup or scale-up environment
What We’re Looking For
Someone who can build, own and operationalise the QARA function — translating regulatory requirements into practical processes that support safe, compliant and scalable product development.
Apply: hr@imagingiq.ai
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