job title: regulatory affairs specialist (siemens)

Your tasks and responsibilities:

· Planning and preparing product related medical device submissions for the products manufactured at the Bangalore factory according to country specific regulatory requirements and maintaining of licensed products (e.g., for USA, EU, India, Latin America, Asia)

• Take responsibility for product / component registrations following respective standards such as BIS, AERB, CDSCO for the products used at the Bangalore factory

• You will provide professional advice to and actively support internal departments, such as product development in implementation and fulfillment of the applicable regulatory requirements (laws, guidelines, regulations) to ensure the registration of the products manufactured.

• Supporting the audits from the respective authorities of the different countries as a part of the product registration process

Your qualifications and experience:

• You have a diploma or degree in engineering, or a comparable field of study with relevant knowledge of imaging procedures (e.g., radiography, fluoroscopy) and clinical interventional procedures

• You have 4-5 yrs of experience in medical device registration.

• 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 professional 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 lifecycle management

Your attributes and skills:

• You show a collaborative, inspiring working style, and you can accommodate different personalities in a functional team

• You have excellent written and spoken English communication skills

• You are a great communicator, collaborative, inspiring, and able to accommodate different personalities in a functional team

• You are experienced in working in a demanding environment, and you pursue the aligned strategic targets by prioritization, consolidation, and smart decision making

• We win together: you are a team player; you follow the Siemens Healthineers goals with dedication and passion for the job