Product Manager

Product Manager

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

47 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