Job DescriptionQuality & Regulatory Affairs ManagerMedical Device Software / SaMD

Location: Gurugram, Haryana
Work Mode: On-site, 5 days a week
Experience: 6–10 Years
Reporting To: Founder / CEO
Company: ImagingIQ

About ImagingIQ

ImagingIQ is an AI-powered medical imaging and diagnostics company developing advanced solutions to support radiologists in clinical decision-making. Our technology focuses on AI-assisted medical imaging, 3D visualization, and structured reporting, with current applications in brain MRI oncology and expansion into brain CT, trauma, vascular imaging, and other clinical areas.

We aim to enhance radiology workflows through technology while keeping clinical expertise and radiologist validation at the center of the process.

Role Overview

We are looking for a Quality & Regulatory Affairs Manager to establish, implement, and manage the quality management system and regulatory compliance framework for our AI-enabled medical-device software.

The role will own quality systems, regulatory documentation, design controls, risk management, software validation, audit readiness, and regulatory submissions. The ideal candidate will have hands-on experience in medical-device software, Software as a Medical Device (SaMD), or digital health regulations, with the ability to build practical, scalable quality and regulatory processes in a growing healthcare technology environment.

Key Responsibilities

1. Quality Management System (QMS)

- Establish and maintain an ISO 13485-compliant Quality Management System.
- Develop and manage SOPs, quality policies, document control, training records, change management, and quality governance.
- Conduct quality gap assessments and ensure ongoing compliance with applicable standards and regulations.

2. Regulatory Affairs & Compliance

- Manage regulatory classification, licensing, documentation, and submissions under India's Medical Devices Rules, 2017 (CDSCO).




- Support regulatory strategy and compliance planning for AI-enabled medical-device software.
- Coordinate with regulatory authorities, certification bodies, and external consultants as required.
- Support future regulatory expansion into international markets, including the US FDA framework.

3. Software Quality & Design Controls

- Establish and maintain design controls, software lifecycle documentation, requirements traceability, and design change management.
- Ensure alignment with IEC 62304 and applicable medical-device software requirements.
- Oversee verification and validation (V&V;), testing documentation, and evidence supporting product safety and performance.

4. Risk Management & AI/ML Governance

- Implement risk management processes aligned with ISO 14971.
- Maintain risk assessments, risk control measures, and traceability across product development and validation.
- Support AI/ML model validation, data and model version control, performance monitoring, and change-impact assessments.

5. Audits, CAPA & Post-Market Quality

- Manage CAPA, non-conformances, internal audits, complaints, and quality investigations.
- Maintain audit readiness and support regulatory inspections and certification activities.
- Establish post-market quality processes, including complaint handling and ongoing product performance monitoring.

6. Cross-Functional Collaboration

- Work closely with product, engineering, AI/ML, clinical, and business teams to embed quality and regulatory requirements throughout the product lifecycle.
- Build quality awareness and provide training to relevant teams.
- Manage supplier and external partner quality processes.





Required Qualifications & Experience

- 6–10 years of relevant experience in medical devices, medical-device software, SaMD, or regulated digital health.
- Hands-on experience implementing or managing an ISO 13485-based QMS.
- Practical knowledge of CDSCO regulations and India's Medical Devices Rules, 2017.
- Working experience with ISO 14971, IEC 62304, and medical-device software design controls.
- Experience with risk management, requirements traceability, software verification and validation, and change control.
- Experience managing CAPA, internal audits, non-conformances, and regulatory compliance activities.
- Ability to work closely with software, AI/ML, clinical, and product development teams.
- Strong documentation, analytical, communication, and stakeholder management skills.
- Bachelor's or master's degree in a relevant field.

Preferred Qualifications

- Experience with AI/ML-enabled medical devices or medical imaging / radiology software.
- Familiarity with PACS, RIS, DICOM, and radiology workflows.
- Exposure to FDA 510(k), De Novo, 21 CFR Part 820 / QMSR, or other international regulatory frameworks.
- Knowledge of clinical evaluation, performance evaluation, medical-device cybersecurity, and post-market surveillance.
- Experience with eQMS systems and building quality processes in a startup or scale-up setting.

What We Are Looking For

A hands-on quality and regulatory professional who can build, own, and operationalize the QARA function, translate regulatory requirements into practical processes, and support the development and commercialization of safe, compliant, and reliable AI-enabled medical-device software.

Application

Interested candidates can share their updated CV at [email protected] with the subject line:

Application – Quality & Regulatory Affairs Manager | ImagingIQ

Pay: From ₹1,200,000.00 per year

Work Location: In person

📌 Quality & Regulatory Affairs Manager (Gurugram)
🏢 BECO Ventures
📍 Gurugram