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Ensure the quality of software implementation and the safety, performance and reliability of integrated software and hardware by active participation in architecture, design and code reviews, unit testing, software debugging, system troubleshooting and overall resolution.You will be part of the Global Risk Management Team, developing medical device risk management program and ensuring compliance with international medical device standards. You will provide guidance and support to enable cross-functional teams to develop and maintain risk management files for medical device software, with primary responsibility for the Digital Oncology Information System (OIS)



software portfolio which includes Electronic Medical Record (EMR) and Electronic Health Record (EHR) . This role is key to patient safety.

Summary:
- 5 Years of experience in Leads Risk Management efforts, processes and process improvements for the software Product portfolio, with a main focus on Digital Oncology Information system (OIS) software products.
- Develops and maintains clinical software Risk Management Files that include risk management plans, hazard analyses, risk assessments and post market surveillance.
- Collaborates as risk management file owner with healthcare software development teams to ensure the comprehensive implementation of risk control measures in the clinical software in accordance with risk management procedure and international standard ISO 14971
- Keeps abreast of changes to regulations and applicable standards as they bear on risk management process and risk management file
- Participates in regulatory insp

📌 Medical Device Risk Manager (Pune)
🏢 Siemens Healthineers
📍 Pune