- 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 fi le 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 fi le
- Participates in regulatory inspection and notifi ed body audits as risk management subject matter expert.
- Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-function teams.
- For US applicants, we are looking for Central and Eastern time zones.
- 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
- 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
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Medical Device Risk Manager - Winnipeg, Canada - 0420 Varian Medical Systems Canada, Inc.
Description
Together, we can beat cancer.
At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions.
We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what's possible, to improve people's lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.
If you want to be part of this important mission, we want to hear from you.
Varian currently has an opportunity for a Medical Device Risk Manager. You will be part of the Global Risk Management Team, developing Varian's 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 fi les for Varian's medical devices with primary responsibility for the Digital Oncology portfolio. This role is key to patient safety.Summary:
Minimum Required Skills and Knowledge:
#LI-CORP1
Fighting cancer calls for big ideas.
We envision a world without fear of cancer. Achieving this vision takes dedication and commitment from all of us, every single day. That's why we celebrate and value the distinctly beautiful and intersectional identities of each of our employees. We are a mirror of our patient-base, which allows us to innovate. Big ideas come from everywhere, and the best ideas are fostered by our unique individual experiences. At Varian, we encourage you to bring your whole self to work and believe your bold and authentic perspective will help to power more victories over cancer.
TogetherWeFight
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