Medical Device Risk Manager

• 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.

• 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
• Good written and verbal communication in English language
• Strong 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.

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