MedTech Subject Matter Expert – Edge AI & Connectivity Platform

Job Title : MedTech Subject Matter Expert – Edge AI & Connectivity Platform

Location :

Remote (Global collaboration across US and India time zones)

Some travel may be required for client workshops or audits

Role Overview :

We are seeking a highly experienced MedTech Subject Matter Expert (SME) to lead domain strategy, compliance alignment, and clinical relevance for a next-generation Edge AI & Connectivity Platform. This role is critical to ensuring that the solution aligns with healthcare regulatory requirements, clinical workflows, and emerging standards in connected diagnostics, real-time patient monitoring, and intelligent medical devices.

The SME will interface between engineering teams and client stakeholders, ensuring the solution is clinically viable, regulatory compliant, and technically scalable.

Key Responsibilities :

• Serve as the MedTech domain authority across platform design, development, and validation activities.
• Translate clinical, regulatory, and business requirements into platform architecture guidance, user needs, and technical features.
• Ensure end-to-end alignment with global MedTech standards including :
• FDA 510(k) submission requirements
• HIPAA and data privacy laws
• EU MDR and ISO 13485 QMS
• IEC 62304 for medical device software
• Review technical design documents, requirement specifications, and validation protocols to ensure regulatory readiness.
• Work with solution architects to validate use cases such as remote patient monitoring, connected diagnostics, and real-time health telemetry.
• Collaborate with product and engineering teams to define edge-to-cloud data flows, security models, and interoperability using HL7, FHIR, and DICOM standards.
• Lead compliance documentation for V&V (Verification & Validation), audit support, and risk management (ISO 14971).
• Participate in client-facing workshops, roadmap planning sessions, and technical presentations to drive stakeholder buy-in.
• Stay updated on innovations and trends in Digital Health, Real-time AI / ML in MedTech, Device Interoperability, and emerging FDA guidance.

Required Qualifications and Experience :

Domain and Regulatory Expertise Required :

Preferred Skills & Certifications :

Stakeholder Engagement & Communication :

Why Join This Project :

You’ll be the face of MedTech strategy for a cutting-edge connected healthcare platform designed to reshape patient outcomes and real-time diagnostics. This is an opportunity to work at the intersection of regulatory science, clinical innovation, and applied AI backed by a global delivery team with strong engineering depth and execution maturity.