Quality & Regulatory Affairs Manager

Medical Device Software / Software as a Medical Device (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. 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 continuously improve a proportionate Quality Management System aligned with ISO 13485 and applicable Indian medical-device requirements, including controlled policies, SOPs, templates, records and decision logs.
- Define the document hierarchy and governance model; implement document control, change control, training control, record retention and electronic approval practices across the organisation.
- Lead selection, user-requirement definition, validation and rollout of an eQMS or appropriately controlled hybrid system, ensuring that the system supports rather than obstructs product development.
- Work with leadership and product teams to define intended use, indications, claims, target populations, user profiles and market-specific regulatory pathways for AI-enabled medical-imaging products.
- Own or coordinate product classification, licensing and submission activities under the Medical Devices Rules, 2017 and current CDSCO guidance applicable to medical-device software; maintain readiness for future FDA and other international pathways.
- Serve as the primary coordinator for regulators, notified bodies, certification bodies, external QARA consultants and other quality or regulatory partners, while keeping company leadership informed of decisions, risks and commitments.
- Establish design-control and software-lifecycle processes covering user needs, design inputs and outputs, architecture, verification, validation, configuration, release,



maintenance, change assessment and end-to-end traceability.
- Build and maintain product risk-management processes aligned with ISO 14971, including hazard identification, risk analysis, risk-control verification, residual-risk evaluation, benefit-risk considerations and post-production information.
- Ensure that software, AI/ML, usability, cybersecurity, data, workflow and clinical risks are identified early and connected to requirements, controls, tests, validation evidence and product information.
- Partner with clinical and technical teams on analytical and clinical validation plans, acceptance criteria, study protocols, evidence packages and claim-specific performance reporting.
- Help establish controls for AI/ML data provenance, dataset definitions, annotation and review, training/validation separation, model versioning, subgroup performance, generalisation, known limitations and change impact.
- Plan and conduct internal audits, support certification and regulatory inspections, coordinate management reviews and drive findings through timely root-cause analysis and effective closure.
- Own nonconformance, deviation, CAPA, complaint-handling, incident assessment, vigilance/reportability and post-market surveillance processes appropriate to the product’s maturity and jurisdictions.
- Establish supplier and partner quality processes covering qualification, risk-based evaluation, quality agreements, performance monitoring and audit where required for software vendors, cloud services, annotation partners, clinical collaborators and integration partners.
- Coordinate with security, privacy, legal and technology owners on applicable data-protection, cybersecurity and information-security requirements; maintain clear ownership and evidence without duplicating other functions.
- Train teams on practical quality and regulatory responsibilities and build a culture in which quality evidence is created as part of normal work rather than reconstructed immediately before an audit.

Required qualifications

- 6–10 years of experience in quality assurance, quality systems or regulatory affairs, including substantial direct experience in medical devices, medical-device software, digital health or SaMD.
- Hands-on experience implementing, maintaining or significantly improving an ISO 13485-based Quality Management System, including document control, training, management review, internal audit, CAPA and supplier quality.
- Practical experience with Indian medical-device regulation and CDSCO processes, including interpretation of the Medical Devices Rules, 2017, classification, licensing or submission documentation.
- Working knowledge of medical-device software lifecycle and risk-management expectations, including IEC 62304 and ISO 14971, and the ability to translate them into usable engineering and product-development controls.
- Experience with design controls, requirements and risk traceability, verification and validation evidence,



configuration/change control and release documentation for software products.
- Experience preparing for and participating in internal audits, certification audits, regulatory inspections or partner quality assessments, with demonstrated ownership of findings and remediation.
- Ability to review technical, clinical and operational evidence critically and identify gaps without losing sight of the product’s intended use, risk and stage of development.
- Strong written communication and documentation skills, with the ability to produce clear procedures, regulatory rationales, submissions, quality records and executive updates.
- Ability to work directly with software engineers, AI/data-science teams, clinicians and business leadership, and to convert regulatory obligations into proportionate, executable controls.
- Bachelor’s or Master’s degree in Engineering, Pharmacy, Life Sciences, Biomedical Sciences, Quality Management, Regulatory Affairs or a related discipline.

Preferred qualifications

- Experience with AI/ML-enabled medical devices, medical imaging, radiology software, clinical decision support, PACS or other healthcare interoperability environments.
- Exposure to FDA medical-device pathways and the Quality Management System Regulation (21 CFR Part 820), including preparation for a 510(k), De Novo or comparable software-device submission.
- Familiarity with IEC 62366-1 usability engineering, IEC 82304-1 health-software product safety, current medical-device cybersecurity expectations, IMDRF SaMD guidance and Good Machine Learning Practice principles.
- Experience developing or reviewing clinical evaluation, performance evaluation, post-market surveillance or real-world performance plans for software-driven products.
- Experience selecting, configuring or validating an eQMS and integrating controlled quality processes with engineering tools such as issue trackers, source control, test-management or document repositories.
- Recognised training or certification in regulatory affairs, ISO 13485 auditing, quality management or medical-device risk management.
- Experience establishing a QARA function in a startup, scale-up or product organisation moving from pilot/UAT into controlled clinical deployment.

What success looks like

- ImagingIQ has an agreed regulatory pathway and claim strategy for each active product, with material assumptions and decisions recorded and controlled.
- The organisation operates a usable QMS with explicit ownership, trained teams, controlled records and evidence that can be retrieved without last-minute reconstruction.
- Design, software, risk, clinical and validation evidence is traceable across the product lifecycle and is kept current as models and workflows change.
- Audit and submission readiness improves according to a realistic, risk-based roadmap, with gaps surfaced early and closed through accountable actions.
- Quality controls enable safe, disciplined execution while remaining proportionate to the company’s size, product maturity and actual regulatory risk.

Why this role matters

This role will shape how ImagingIQ moves from technically capable AI systems to responsibly governed medical-device products. You will have direct influence over regulatory strategy, product evidence, release discipline and quality culture at a stage when the right foundations can materially improve both clinical trust and the company’s ability to scale.

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