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 inspection and notified body audits as risk management subject matter expert.
Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-function teams.

Minimum Required Skills and Knowledge:
Bachelor s degree in Healthcare, Science or Engineering with several years of related experience




At least 3 years of relevant experience in medical device risk management or digital electronic health record system
At least 3 years of relevant experience in Healthcare Software Development
Knowledge in ISO 13485, ISO 14971, FDA CFR 820, EU 2017/745, IEC 62304, IEC 82304 and IEC/TR 80002-1
Medical Device Risk analysis, risk control measure evaluation, implementation and validation testing experience
Valuable written and verbal communication in English language
Solid interpersonal skills
Knowledge and understanding of international safety standards for medical devices
Related experience with US Class II or III (EU class IIb or III) medical devices is highly desired
Related experience with Software as a Medical Device (SaMD), Risk analysis and Cybersecurity Risk management
Proficient in utilizing business tools such as: Outlook, Microsoft Word, Excel, and PowerPoint.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Medical Device Risk Manager Pune
🏢 Varian Medical Systems International India
📍 Pune