【PM】Product Manager_AMED

Position Overview
As a Product Manager for our core AI-based Software as a Medical Device (SaMD) portfolio, you will own the product lifecycle from initial concept to market launch (0 to 1). You will bridge the gap between cutting-edge medical AI engineering, strict regulatory standards, and commercial viability. This role is highly cross-functional, requiring you to lead software development cycles, navigate regulatory clearances, maintain Quality Management System (QMS) compliance, and design proof-of-concept (PoC) frameworks that validate both clinical and business value.

Key Responsibilities
1. End-to-End Product Ownership (0 to 1)

• Concept to Launch: Define and execute the 0-to-1 product strategy, roadmap, and timeline for our AI-based SaMD portfolio, aligning company strategy with clinical market needs.
• Requirements Definition: Translate clinical needs and technical capabilities into clear user stories, use scenarios, product positioning, and technical specifications for the engineering team.
• Lifecycle Management: Oversee the entire product lifecycle, optimizing post-launch iterations based on user feedback, data analytics, and evolving clinical workflows.

2. Regulatory Clearance & QMS Compliance

• Regulatory Alignment: Partner with regulatory affairs to define clearance pathways and integrate regulatory requirements directly into the early software development scope.
• QMS Documentation: Take active, hands-on ownership of QMS-related administrative paperwork and technical documentation to ensure development processes strictly adhere to medical device standards (e.g., ISO 13485, IEC 62304).
• Submission Support: Author and compile documents for regulatory submissions.

3. Go-to-Market (GTM) & Proof of Concept (PoC)

• PoC Frameworks: Design and establish diverse Proof of Concept initiatives, including early-stage clinical validations and business concept testing at target healthcare institutions.
• Commercial Launch Strategy: Collaborate closely with the sales and marketing teams to build the GTM strategy, including product positioning, feature availability tiering, and value proposition mapping for hospital administration.
• Cross-Functional Collaboration: Serve as the central hub connecting R&D, commercial teams, healthcare providers, and government agencies to ensure seamless execution and commercial success.

4. Product Analytics & Continuous Improvement

• Data-Driven Insights: Analyze product success data (e.g., user engagement, use rates, system error rates) to rapidly identify friction points, optimize software performance, and prioritize the product backlog.