3.0 - 7.0 years

0 Lacs

karnataka

On-site

As a Lead QMS at Ai Health Highway, you will play a crucial role in implementing Quality Management System (QMS), ISO13485, EU MDR, and US FDA (510k) Risk Management processes for our cutting-edge medical devices. Your responsibilities will include creating device master records, updating technical documentation, and collaborating with internal and external stakeholders to establish a robust quality management and regulatory framework for our product pipeline. You will work closely with engineering and manufacturing teams to develop verification test strategies to ensure the safety and reliability of our products. Additionally, you will be involved in developing product requirements, supporting validation programs for new product development, and providing inputs for regulatory guidelines and procedures. Your expertise in risk assessment for medical devices, as per ISO13485/ISO 14971 CE certification, will be essential in this role. You will also be responsible for reviewing device labelling and advertising materials for compliance with regulations, liaising with external consultants, and assisting in documentation preparation for US FDA (510k) and EU-CE Marking regulatory submissions. To be successful in this position, you should have 3 to 5 years of experience in the Medical Device QMS and regulatory domain, along with a BTech/BE in Electronics/Electrical/CS or Bio-Medical Engineering. Strong skills in documentation, review, reporting, and excellent interpersonal communication are required. Experience in managing non-conformance, corrective action preventive actions, deviation, and conducting QMS training will be beneficial. Join us at Ai Health Highway in our mission to reduce premature deaths due to Non-Communicable Diseases by 30% by 2030. Your expertise and dedication will contribute significantly to our goal of revolutionizing healthcare with innovative medical devices.,

Posted 3 weeks ago

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