Medical Device Risk Manager

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

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 14971Keeps abreast of changes to regulations and applicable standards as they bear on risk management process and risk management fi leParticipates 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.

Minimum Required Skills And Knowledge

Bachelor’s degree in Healthcare, Science or Engineering with several years of related experienceAt least 3 years of relevant experience in medical device risk management or digital electronic health record systemAt least 3 years of relevant experience in Healthcare Software DevelopmentKnowledge in ISO 13485, ISO 14971, FDA CFR 820, EU 2017/745, IEC 62304, IEC 82304 and IEC/TR 80002-1Medical Device Risk analysis, risk control measure evaluation, implementation and validation testing experienceGood written and verbal communication in English languageStrong interpersonal skillsKnowledge and understanding of international safety standards for medical devicesRelated experience with US Class II or III (EU class IIb or III) medical devices is highly desiredRelated experience with Software as a Medical Device (SaMD), Risk analysis and Cybersecurity Risk managementProficient in utilizing business tools such as: Outlook, Microsoft

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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Varian is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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The base pay range for this position is

Min $66,100 - Max $116,000

The pay wage range shown is based on the job posting's primary location. Actual compensation packages are based on a wide array of factors, including but not limited to skill set, experience, certifications, and location.