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 new 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 setting ● 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)
🏢 Ai Health Highway
📍 Bengaluru