Product Manager

Job 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 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