Medical Device Risk Manager
7 days ago
Together, let's defeat cancer
Join Varian, a Siemens Healthineers Company, where we gather the top talents worldwide to make our dream of a cancer-free world a reality. Together, we passionately develop and provide user-friendly, effective oncology solutions.
We are part of an amazing community of professionals exploring the limits of what's achievable to enhance lives globally. We foster an inclusive culture where every individual's potential shines. We ignite ideas that drive positive outcomes and sustained achievements.
If you are eager to contribute to this crucial mission, we would love to hear from you.
Varian is currently seeking a Medical Device Risk Manager. In this role, you will be part of the Global Risk Management Team, shaping Varian's medical device risk management program to meet international standards. You will guide cross-functional teams in creating and updating risk management files for Varian's medical device software, focusing on the Digital Oncology Information System (OIS) software portfolio, including Electronic Medical Record (EMR) and Electronic Health Record (EHR). This position plays a significant role in ensuring patient safety.
Summary:
- 5 Years of experience leading Risk Management efforts for Varian's software Product portfolio, particularly the Digital Oncology Information System (OIS) software products.
- Develops and maintains clinical software Risk Management Files, including risk management plans, hazard analyses, risk assessments, and post-market surveillance.
- Collaborates with healthcare software development teams as the risk management file owner to ensure comprehensive implementation of risk control measures as per Varian's procedure and ISO 14971 standard.
- Stays updated on regulatory changes affecting the risk management process and files.
- Participates in regulatory inspections and notified body audits as a risk management expert.
- Drives continuous improvement through cross-functional team facilitation and leadership.
Minimum Required Skills and Knowledge:
- Bachelor's degree in Healthcare, Science, or Engineering with relevant experience.
- Minimum 3 years of experience in medical device risk management or digital electronic health record systems.
- Minimum 3 years of experience in Healthcare Software Development.
- Knowledge of various standards like ISO 13485, ISO 14971, FDA CFR 820, EU 2017/745, IEC 62304, IEC 82304, and more.
- Experience in medical device risk analysis, risk control measures, and validation testing.
- Effective written and verbal communication skills in English.
- Strong interpersonal abilities.
- Understanding of international safety standards for medical devices.
- Experience with US Class II or III (EU class IIb or III) medical devices and Software as a Medical Device (SaMD), Risk analysis, and Cybersecurity Risk management.
- Proficiency in business tools such as Outlook, Microsoft Word, Excel, and PowerPoint.
- Familiarity with Varian software products is advantageous.
Varian is committed to complying with all local regulations, including potential vaccine requirements for specific roles.
Conquering cancer requires innovative thinking.
Our vision is a cancer-free world, and achieving it demands commitment and daily dedication. That's why we cherish and respect the diverse identities of our employees. Our diversity mirrors our patient base, fostering innovation. Great ideas can come from anywhere, and our unique experiences nurture the best ideas. At Varian, we encourage you to bring your true self to work, believing that your bold, authentic perspective will lead to more victories against cancer.
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