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:
- 10–18 years of experience in the Medical Device or Digital Health industry, preferably with exposure to edge, IoT, or AI-based solutions.
- Proven track record of working on regulated healthcare products (Class I, II, or III medical devices).
- Deep understanding of clinical workflows, device lifecycle management, and digital transformation within hospitals or diagnostics labs.
- Prior experience working on product submissions to FDA, CE, or other regulatory authorities.
- Strong grasp of software design controls, clinical risk management, usability engineering, and medical data privacy.
Domain and Regulatory Expertise Required:
- Medical device software development lifecycle (IEC 62304)
- Quality management systems (ISO 13485)
- Risk management standards (ISO 14971)
- Data privacy & security regulations (HIPAA, GDPR)
- FDA regulatory pathways (e.g., 510(k), De Novo)
- EU MDR guidelines and documentation requirements
- Medical interoperability protocols: HL7, FHIR, DICOM
Preferred Skills & Certifications:
- RAC Certification (Regulatory Affairs Certification)
- Certified HIPAA Professional (CHP)
- Biomedical Engineering, Clinical Informatics, or HealthTech Product Development background
- Experience working with cloud-to-edge data platforms (e.g., Azure IoT, GCP Edge, AWS Greengrass)
- Familiarity with cybersecurity for medical devices (e.g., FDA Pre-market Guidance for Cybersecurity)
Stakeholder Engagement & Communication:
- Comfortable presenting complex regulatory and clinical content to technical and non-technical stakeholders.
- Prior experience leading workshops, requirement elicitation sessions, and technical steering committees.
- Ability to work closely with product managers, clinical advisors, embedded engineers, and cloud/AI architects.
- Strong documentation and writing skills for review of QMS documentation, SoPs, and V&V reports.
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.