Your tasks and responsibilities:

Analyzing global requirements for product registration and support the creating, shaping, and maintaining process framework for the implementation of the necessary activities in the pre- and post-market phases
Planning and preparing product related medical device submissions with Siemens Healthineers internal regional units according to country specific regulatory requirements and maintaining of licensed products (e.g., for India, Latin America, Asia)
Take responsibility for component registrations following respective standards such as BIS, CCC and NOM of relevant parts of the Siemens Healthineers AT products
You will provide professional advice to and actively support internal departments, such as product management, (clinical) marketing- and product development in implementation and fulfillment of global regulatory requirements (laws, guidelines, regulations) for registration of medical devices
Following a Clinical and Product Lifecycle Management approach together with the interfacing departments, to ensure optimal utilization of synergies,



operational efficiency, and regulatory compliance essential for the major markets
Supporting the creation of clinical evaluation reports for the EU and China ensuring compliance with applicable regulations and timely provision to authorities

Your qualifications and experience:

You have a university degree in medical engineering, or a comparable field of study with relevant knowledge of imaging procedures (e.g., radiography, fluoroscopy) and clinical interventional procedures
You have knowledge of the pertinent regulatory frameworks of the EU, China, India, and Latin America. Experience regarding USA registrations would be beneficial
You have skilled experience in the regulatory affairs functions or in comparable positions in the medical device industry, and you are very familiar with relevant interfacing processes, such as product risk management, post-market surveillance, and product

📌 Regulatory Affairs Professional (Bengaluru)
🏢 Siemens Healthineers
📍 Bengaluru