Systems Engineer Legal And Regulatory

This is a role well suited to an ambitious professional, looking for the next step in their career. As Systems Engineer Legal within Research and Development, Advanced Therapies, Bangalore, you will be responsible for:

• Leading risk management topics by preparing the risk analysis and documentation as per the ISO 14971 standards
• Evaluating impact on X-ray surgery product portfolio due to Country specific Standards and Regulations
• Leading and monitoring engineering change activities related to standards, regulations and compliance topics
• Monitoring and supporting Compliance and Regulatory product Testing; Prepare compliance testing documentation with regulatory labs
• Leading usability engineering activities for the product portfolio and own technical writing of user documentation
• Planning and monitoring the FDA preparatory efforts for product launches within the US
• Global ownership of SOP development within the areas of risk engineering, usability, regulations and user documentation
• Leading the Research and development department in various internal and external audits
  
  

• At least 4-6 years’ experience in R&D areas such as electronics engineering or similar
• University degree in Electrical & Electronics/ Communications Engineering preferably supplemented with work experience in the areas of standards, risk management and compliance testing
• Deep knowledge of Change Management processes, Regulatory audits and risk engineering
• Experience in FDA preparatory experience, BIS / EU MDR system qualification
• Knowledge of product lifecycle management process including R&D and engineering processes and all relevant interfaces between phases and to other processes
• Knowledge of healthcare domain-specific products and technologies, preferably with background experience of medical diagnostic x-ray engineering.
• Knowledge in PCB and cable Harness development processes is a plus
• Fluent English skills both in verbal and written form