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18 Varian Medical Systems International India Jobs
Medical Device Risk Manager
5-10 years
Pune
1 vacancy
Medical Device Risk Manager
Varian Medical Systems International India
posted 9hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Summary:
- 5 Years of experience in Leads Risk Management efforts, processes and process improvements for the Varian software Product portfolio, with a main focus on Varian s 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 Varian s 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
- 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.
- A knowledge of Varian software products is a plus
Employment Type: Full Time, Permanent
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based on 60 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Varian Medical Systems International India Benefits
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