AI Radiology Solutions Lead

As a Product Manager at mlHealth 360 , you will lead the next phase of development for

our AI-driven Radiology solutions, including medical imaging diagnostic AI products.

The ideal candidate will combine technical acumen, clinical understanding, and

regulatory awareness to drive end-to-end product lifecycle — from concept to

deployment and compliance with Indian SaMD regulations.

Key Responsibilities

1. Product Strategy & Roadmap

• Define and own the product roadmap for AI-based radiology applications in CT,

MRI, and X-ray domains.

and differentiation opportunities.

market strategy.

2. Product Development & Execution

specifications and user stories.

high-quality product releases.

usability testing.

3. Regulatory & Quality Compliance (SaMD)

62304, ISO 14971, and MDR (India) requirements for Software as a Medical

Device.

o Risk management files and traceability matrices.

o Clinical evaluation and post-market surveillance plans.

o Change control and version management procedures.

markets (e.G., CE, FDA if applicable).

4. Stakeholder Engagement

feedback and validate clinical workflows.

demos, training, and go-to-market launches.

stakeholders.

5. Data, AI, and Platform Integration

annotation processes.

protocols, and model integration pipelines.

DICOM, HL7, FHIR)

Required Skills and Qualifications :

Education

related field.

Administration is a plus.

Experience

(preferably in medical imaging, digital health, or SaMD).

or clinical workflow systems preferred.

13485, IEC 62304, and related frameworks.

teams.

Technical & Domain Skills

integration.

and deployment.

(Docker / Kubernetes).

Soft Skills

strategies.