Ai Health Highway
Website:
aisteth.com
Job details:
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 environment
● 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
Click on Apply to know more.
_1559790947474.png){kind=logo}
