Product Manager (Onsite or Remote)

Role Description

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.
• Conduct market and competitive analysis to identify gaps, unmet clinical needs, and differentiation opportunities.
• Collaborate with leadership to align product goals with company vision and market strategy.

2. Product Development & Execution

• Translate clinical and business requirements into actionable product specifications and user stories.
• Work closely with AI/ML, software engineering, and UX teams to ensure timely, high-quality product releases.
• Participate in sprint planning, backlog grooming, and product reviews.
• Drive validation activities, including performance testing, reader studies, and usability testing.

3. Regulatory & Quality Compliance (SaMD)

• Ensure product design and documentation comply with CDSCO, ISO 13485, IEC 62304, ISO 14971, and MDR (India) requirements for Software as a Medical Device.
• Collaborate with QA/RA teams on:

o Risk management files and traceability matrices.

o Clinical evaluation and post-market surveillance plans.

o Change control and version management procedures.

• Support technical file preparation for CDSCO submission and other international markets (e.g., CE, FDA if applicable).

4. Stakeholder Engagement

• Work closely with radiologists, clinicians, and hospital IT teams to capture feedback and validate clinical workflows.
• Liaise with sales, marketing, and customer success teams to support pre-sales demos, training, and go-to-market launches.
• Communicate product vision and performance to internal and external stakeholders.

5. Data, AI, and Platform Integration

• Understand and evaluate AI model performance metrics, datasets, and annotation processes.
• Collaborate with the AI team to define dataset requirements, validation protocols, and model integration pipelines.
• Support deployment of cloud-based and PACS-integrated AI workflows (e.g., DICOM, HL7, FHIR)

Required Skills and Qualifications:

Education

• Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, or
• related field.
• Master’s in Healthcare Technology, Product Management, or Business Administration is a plus.

Experience

• 4–7 years of total experience, including 2+ years in product management (preferably in medical imaging, digital health, or SaMD).
• Experience with AI-based medical imaging solutions, cloud/SaaS platforms, or clinical workflow systems preferred.
• Working knowledge of Indian regulatory requirements for SaMD — CDSCO, ISO 13485, IEC 62304, and related frameworks.
• Prior experience working with cross-functional R&D and clinical validation teams.

Technical & Domain Skills

• Understanding of CT/MRI modalities, DICOM standards, and PACS/RIS integration.
• Familiarity with AI/ML lifecycle concepts — model training, testing, validation, and deployment.
• Exposure to cloud platforms (AWS/Azure/GCP), APIs, and containerization (Docker/Kubernetes).
• Proficiency with Agile tools (Jira, Confluence, Asana).

Soft Skills

• Strong analytical and problem-solving mindset.
• Excellent communication and stakeholder management abilities.
• Ability to translate complex clinical and technical concepts into clear product strategies.
• Passion for improving healthcare outcomes through AI innovation