ABOUT US

Ai Health Highway is a MedTech start-up focusing on developing medical devices to screen, detect & predict Chronic Diseases using state of the art technology. We are backed by Turbostart, Rainmatter by Zerodha, The Chennai Angels, Social Alpha (Tata Trusts) Maine Technology

Institute (US), Sound Hub/Accelerace (Denmark) & FSID/IISC (India) Ai Health Highway was part of Google for Ai First India 2025 cohort and IndiaAI Mission's Startups Global Acceleration Program at STATION F HEC Paris. Our GOAL is to reduce 30% premature deaths due to Non-communicable Disorders (NCDs) by 2030 Responsibilities

● Lead QMS & Risk Management initiatives

● Create device master records/design history files and update technical documentation and records

● Develop product requirements /technical specifications based on the DHF gap assessment

● Work with engineering & manufacturing teams to develop robust verification test strategies to ensure product safety and reliability

● Provide inputs into design of products in development & support validation programs for current product development.





● Work with cross-functional teams to develop regulatory guidelines and procedures

● Review device labelling and advertising materials for compliance with regulations; analyse and recommend appropriate changes

● Liaise with external consultants and internal team to help with documentation preparation for the US FDA and EU-CE marking regulatory submissions. Requirements

● 3 to 5 years experience in Medical Device QMS and regulatory domain

● BTech/BE in Electronics/Electrical/CS or Bio-Medical Engineering with experience in quality role in engineering, manufacturing workplace

● Prior experience in risk assessment for medical devices as per ISO13485/ISO 14971, US FDA 510k SaMD, CE certification

● Experience in Documentation, Review & Reporting areas & excellent interpersonal communication skills

● Manage non-conformance, corrective action preventive actions and deviation.

Conduct required QMS training to all employees and monitor the training coverage and effectiveness

● Trained Internal Auditor

📌 Qms & Regulatory Lead Medtech Bengaluru (India)
🏢 Ai Health Highway
📍 India